8
The #1 Synthetic Bone Graft 1

Vito Ss Comprehensive b

Embed Size (px)

DESCRIPTION

hydroxyapatite

Citation preview

  • The Gold Standard2

    VITOSS is FDA cleared for use in the pelvis,the extremities, and posterolateral spine.

    BMA Harvesting Sites

    What makes Iliac Crest Bone Graft (ICBG) the gold standard?

    Bone marrow can easily be aspirated from several anatomical locations throughout thebody. VITOSS can be used with or without bone marrow aspirate.

    Autograft (ICBG) VITOSS and BMA

    Signal

    Cells

    Scaffold

    VITOSS + BMA = synthetic autograft

    VITOSS resembles ICBG, the goldstandard, in that it has the samethree components: SCAFFOLD,

    CELLS, and SIGNALS.3

    Iliac Crest Bone Graft (ICBG) has a Calcium Phosphate(CaP) surface with an open, inter-connected structurethat serves as a scaffold.

    ScaffoldScaffold

    Cells & SignalsCells & Signals

    Bone marrow is a biologic driver found in ICBG.

    ICBG contains bone marrow rich withmesenchymal stem cells and hematopoeticstem cells that facilitate bone regenerationand neo-vascularization. In addition, ICBGprovides signals that help drive bone formation.

    Iliac Crest (PSIS, ASIS) Calcaneus

    Vertebral Body(via pedicle)

    Evidence Based Medicine

    The #1 Synthetic Bone Graft1

    The Cumulative Number of Bone Graft Products 510(k) Cleared4

    Currently, there are over 180 510(k) clearances for orthopaedic bone graftproducts. Because of the vast number of products available, it is oftendifficult for surgeons to assess the best choices for bone grafting.5

    Epstein, N.E., An analysis of Noninstrumented Posterolateral Lunbar Fusions Performedin Predominantly Geriatric Patients Using Lamina Autograft and Beta-Tricalcium Phos-phate. The Spine Journal, February 2008.Study Design:Prospective; 60 patients using Noninstrumented PLF; Average age = 70 yearsOutcome Measures:CT scans - Fusion assessment; Dynamic X-rays; Fusion assessed separately by 2 neuro-radiologists blinded to the treatment; Post-operative outcomes using SF-36; 3, 6, 12, and24 months follow upResults:Successful fusion in 85% of patients (51/60) when judged by CT and F/E

    Epstein, N.E., Beta-Tricalcium Phosphate: Observation of Use in 100 PosterolateralLumbar Instrumented Fusions. The Spine Journal, June 2009.Study Design:Prospective; 100 patients with lumbar spinal stenosis; Multisegment laminectomies (avg. 3.6segments) and one segment (78 patients) or two segment (22 patients) instrumented PLFOutcome Measures:Dynamic X-rays; 2D-CT Scans; Post-operative outcomes using SF-36; Fusion assessedseparately by 2 neuroradiologists blinded to the treatment; 3, 4.5, 6, and 12 month followup with a minimum of 2.5 years and maximum of 5.0 years (avg. 3.1 years)Results:Successful fusion in 95% of patients (95/100) when judged by CT and Dynamic X-ray

    VITOSS continues to be the #1 Synthetic Bone Graft for the simplest ofreasons...IT WORKS and has HUMAN CLINICAL DATA to support its efficacy.

    Clinical Experience - Over 375,000 implantations worldwide6

    Clinical Proof - Numerous human clinical studies (including pro-spective and peer reviewed) demonstrating VITOSS with autologousbone marrow is an effective autograft replacement.7

    The vast majority of products have no human clinical data to support their use.5

    Ultimately, human clinical data should be used to select a bone graft.

    The #1 SyntheticBone Graft1

    45 Great Valley ParkwayMalvern, PA 193551.888.774.8870 (tel)1.610.640.2603 (fax)

    www.stryker.com

    1 - Millennium Research Group: US Markets for Orthopedic Biomaterials 2010. 2 - Peter Ullrich Jr., Autograft: The Patient's Own Bone. Published in 9/8/99 and updated on 11/25/09 on Spine Universe. 3 - Bellincampi, L., Clineff, T., Erbe, E., Osteoinductivity of Vitoss with Isologous Bone Marrow in Urist Rat Pouch Model. Society for Biomaterials, Tampa, FL, April 24-27, 2002 (Podium). 4 - www.fda.gov, MQV products, November 2007. 5 - The Evolving Role of Bone Graft Substitutes. American Academy of Orthopaedic Surgeons 77th Annual Meeting, March 9-13, 2010. 6 - Stryker Orthobiologics Internal Sales Data, July 2011. 7 - Vitoss Bibliography, P/N 5606-0117 Rev. 00, 2010. 8 - Motomiya, M., et al., Effect of Hydroxyapatite Porous Characteristics on Healing Outcomes in Rabbit Posterolateral Spinal Fusion Model. European Spine Journal, 2007; 16: 2215-2224. 9 - Orthovita Test Report P/N 1070-0008R.10 - Orthovita Test Report P/N 1050-0003R.11 - Characteristics of Vitoss BA Product.12 - Hench, L.L., Splinter, R.J., and Allen, W.C., Bonding Mechanisms at the Interface of Ceramic Prosthetic Materials. Journal of Biomedical Materials Research, 1971; 2(1): 117-141.13 - Hench, L.L., Paschall, H.A., Direct Chemical Bond of Bioactive Glass-Ceramic Materials to Bone and Muscle. Journal of Biomedical Materials Research, 1973; 4: 25-42.14 - Gross, U., The Interface of Various Glasses and Glass Ceramics with a Bony Implantation Bed. Journal of Biomedical Materials Research, 1985; 19: 251-271.15 - Sanders, D.M., Hench, L.L., Mechanisms of Glass Corrosion. Journal of American Ceramic Society. 1973; 56(7): 373-377.16 - Hench, L.L., Characterization of Glass Corrosion and Durability. Journal of Non-Crystalline Solids, 1975; 19: 27-39.17 - Ogino, M., Hench, L.L., Formation of Calcium Phosphate Films on Silicate Glasses. Journal of Non-Crystalline Solids, 1980; 38 and 39: 673-678.18 - Vrouwenvelder, W.C.A., Histological and Biochemical Evaluation of Osteoblasts Cultured on Bioactive Glass, Hydroxyapatite, Titanium Alloy, and Stainless Steel. Journal of Biomedical Materials Research, 1993 Apr; 27(4): 465-75.19 - Hench, L.L., The Story of Bioglass. Journal of Materials Science: Materials in Medicine, 2006 Nov; 17(11): 967-78.20 - Oonishi, H., et al., Particulate Bioglass Compared with Hydroxyapatite as a Bone Graft Substitute. Clinical Orthopaedics and Related Research, 1997 Jan; 334: 316-25.21 - Xynos, I.D., Edgar, A.J., Buttery, L.D.K., Hench, L.L., and Polak, J.M., Ionic Products of Bioactive Glass Dissolution Increase Proliferation of Human Osteoblasts and Induce Insulin-like Growth Factor II mRNA Expression and Protein Synthesis. Biochemical and Biophysical Research Communications, 2000 September 24; 276(2): 461-5.22 - Anker et al, Ultraporous Beta-Tricalcium Phosphate is Well Incorporated in Small Cavitary Defects. Clinical Orthopaedics and Related Research, 2005 May; 434: 251-7.23 - Brown, LS, Darmoc, MM, Owsiany, RS, Clineff, TD, Improvements in Healing with a Bioactive Bone Graft Substitute in a Canine Metaphyseal Defect. 55th Annual Meeting of the Orthopaedic Research Society, 2009.24 - Havener, MB, Clineff, TD, Darmoc, MM, Brown, LS, Owsiany, R, A Comparative Study of Synthetic Bone Graft Substitutes in a Canine Metaphyseal Defect. 54th Annual Meeting of the Orthopaedic Research Society, 2008.25 - Marx, J., Bone Marrow: A Validated Biological Driver for Bone Regeneration, White Paper. 26 - Muschler, G.F., Nakamoto, C., Griffith, L.G., Engineering Principles of Clinical Cell-Based Tissue Engineering. Journal of Bone and Joint Surgery, 2004; 86(7): 1541.27 - Curylo, L.J., et al., Augmentation of Spinal Arthrodesis With Autologous Bone Marrow in a Rabbit Posterolateral Spine Fusion Model. Spine, 1999 March 1, 24(5 ): 434-8.28 - Deakin, D.E., Bannister, G.C., Graft Incorporation After Acetabular and Femoral Impaction Grafting With Washed Irradiated Allograft and Autologous Marrow. The Journal of Arthroplasty, 2007 January; 22(1): 89-94.29 - Kim, K.J., et al., Effect of Bone Marrow Grafting on the Titanium Porous-Coated Implant in Bilateral Total Knee Arthroplasty. Acta Orthopaedica, 2007 February; 78(1): 116-22.

    A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particularproduct when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons betrained in the use of any particular product before using it in surgery. The information presented in this brochure isintended to demonstrate a Stryker product. Always refer to the package insert, product label and/or user instructionsbefore using any Stryker product. Products may not be available in all markets. Product availability is subject to theregulatory or medical practices that govern individual markets. Please contact your Stryker representative if you havequestions about the availability of Stryker products in your area.

    Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarksor service marks: Imbibe, Stryker, Vitoss. All other trademarks are trademarks of their respective owners or holders.

    Literature Number: 5701-0000 Rev. 00AQ/LW 08/11

    Copyright 2011 StrykerPrinted in USA

    Num

    ber o

    f Bon

    e G

    raft

    Pro

    duct

    s

    Year

    200180160140120100806040200

    1996

    1997

    1998

    1999

    2000

    2001

    2002

    2003

    2004

    2005

    2006

    2007

    EMS Equipment

    Patient Handling Equipment

    Imaging

    Communications

    Endoscopy

    Navigation

    Interventional Spine

    Neuro & ENT

    Surgical Products

    Orthobiologics

    Spine

    Craniomaxillofacial

    Trauma, Extremities, Deformities

    Joint Replacements

  • The Gold Standard2

    VITOSS is FDA cleared for use in the pelvis,the extremities, and posterolateral spine.

    BMA Harvesting Sites

    What makes Iliac Crest Bone Graft (ICBG) the gold standard?

    Bone marrow can easily be aspirated from several anatomical locations throughout thebody. VITOSS can be used with or without bone marrow aspirate.

    Autograft (ICBG) VITOSS and BMA

    Signal

    Cells

    Scaffold

    VITOSS + BMA = synthetic autograft

    VITOSS + BMA resembles ICBG, thegold standard, in that it has the same

    three components: SCAFFOLD,CELLS, and SIGNALS.3

    Iliac Crest Bone Graft (ICBG) has a Calcium Phosphate(CaP) surface with an open, inter-connected structurethat serves as a scaffold.

    ScaffoldScaffold

    Cells & SignalsCells & Signals

    Bone marrow is a biologic driver found in ICBG.

    ICBG contains bone marrow rich withmesenchymal stem cells and hematopoeticstem cells that facilitate bone regenerationand neo-vascularization. In addition, ICBGprovides signals that help drive bone formation.

    Iliac Crest (PSIS, ASIS) Calcaneus

    Vertebral Body(via pedicle)

    Evidence Based Medicine

    The #1 Synthetic Bone Graft1

    The Cumulative Number of Bone Graft Products 510(k) Cleared4

    Currently, there are over 180 510(k) clearances for orthopaedic bone graftproducts. Because of the vast number of products available, it is oftendifficult for surgeons to assess the best choices for bone grafting.5

    Epstein, N.E., An Analysis of Noninstrumented Posterolateral Lumbar Fusions Performedin Predominantly Geriatric Patients Using Lamina Autograft and Beta-Tricalcium Phos-phate. The Spine Journal, February 2008.Study Design:Prospective; 60 patients using Noninstrumented PLF; Average age = 70 yearsOutcome Measures:CT scans - Fusion assessment; Dynamic X-rays; Fusion assessed separately by 2 neuro-radiologists blinded to the treatment; Post-operative outcomes using SF-36; 3, 6, 12, and24 months follow upResults:Successful fusion in 85% of patients (51/60) when judged by CT and F/E

    Epstein, N.E., Beta-Tricalcium Phosphate: Observation of Use in 100 PosterolateralLumbar Instrumented Fusions. The Spine Journal, June 2009.Study Design:Prospective; 100 patients with lumbar spinal stenosis; Multisegment laminectomies (avg. 3.6segments) and one segment (78 patients) or two segment (22 patients) instrumented PLFOutcome Measures:Dynamic X-rays; 2D-CT Scans; Post-operative outcomes using SF-36; Fusion assessedseparately by 2 neuroradiologists blinded to the treatment; 3, 4.5, 6, and 12 month followup with a minimum of 2.5 years and maximum of 5.0 years (avg. 3.1 years)Results:Successful fusion in 95% of patients (95/100) when judged by CT and Dynamic X-ray

    VITOSS continues to be the #1 Synthetic Bone Graft for the simplest ofreasons...IT WORKS and has HUMAN CLINICAL DATA to support its efficacy.

    Clinical Experience - Over 375,000 implantations worldwide6

    Clinical Proof - Numerous human clinical studies (including pro-spective and peer reviewed) demonstrating VITOSS with autologousbone marrow is an effective autograft replacement.7

    The vast majority of products have no human clinical data to support their use.5

    Ultimately, human clinical data should be used to select a bone graft.

    The #1 SyntheticBone Graft1

    45 Great Valley ParkwayMalvern, PA 193551.888.774.8870 (tel)1.610.640.2603 (fax)

    www.stryker.com

    1 - Millennium Research Group: US Markets for Orthopedic Biomaterials 2010. 2 - Peter Ullrich Jr., Autograft: The Patient's Own Bone. Published in 9/8/99 and updated on 11/25/09 on Spine Universe. 3 - Bellincampi, L., Clineff, T., Erbe, E., Osteoinductivity of Vitoss with Isologous Bone Marrow in Urist Rat Pouch Model. Society for Biomaterials, Tampa, FL, April 24-27, 2002 (Podium). 4 - www.fda.gov, MQV products, November 2007. 5 - The Evolving Role of Bone Graft Substitutes. American Academy of Orthopaedic Surgeons 77th Annual Meeting, March 9-13, 2010. 6 - Stryker Orthobiologics Internal Sales Data, July 2011. 7 - Vitoss Bibliography, P/N 5606-0117 Rev. 00, 2010. 8 - Motomiya, M., et al., Effect of Hydroxyapatite Porous Characteristics on Healing Outcomes in Rabbit Posterolateral Spinal Fusion Model. European Spine Journal, 2007; 16: 2215-2224. 9 - Orthovita Test Report P/N 1070-0008R.10 - Orthovita Test Report P/N 1050-0003R.11 - Characteristics of Vitoss BA Product.12 - Hench, L.L., Splinter, R.J., and Allen, W.C., Bonding Mechanisms at the Interface of Ceramic Prosthetic Materials. Journal of Biomedical Materials Research, 1971; 2(1): 117-141.13 - Hench, L.L., Paschall, H.A., Direct Chemical Bond of Bioactive Glass-Ceramic Materials to Bone and Muscle. Journal of Biomedical Materials Research, 1973; 4: 25-42.14 - Gross, U., The Interface of Various Glasses and Glass Ceramics with a Bony Implantation Bed. Journal of Biomedical Materials Research, 1985; 19: 251-271.15 - Sanders, D.M., Hench, L.L., Mechanisms of Glass Corrosion. Journal of American Ceramic Society. 1973; 56(7): 373-377.16 - Hench, L.L., Characterization of Glass Corrosion and Durability. Journal of Non-Crystalline Solids, 1975; 19: 27-39.17 - Ogino, M., Hench, L.L., Formation of Calcium Phosphate Films on Silicate Glasses. Journal of Non-Crystalline Solids, 1980; 38 and 39: 673-678.18 - Vrouwenvelder, W.C.A., Histological and Biochemical Evaluation of Osteoblasts Cultured on Bioactive Glass, Hydroxyapatite, Titanium Alloy, and Stainless Steel. Journal of Biomedical Materials Research, 1993 Apr; 27(4): 465-75.19 - Hench, L.L., The Story of Bioglass. Journal of Materials Science: Materials in Medicine, 2006 Nov; 17(11): 967-78.20 - Oonishi, H., et al., Particulate Bioglass Compared with Hydroxyapatite as a Bone Graft Substitute. Clinical Orthopaedics and Related Research, 1997 Jan; 334: 316-25.21 - Xynos, I.D., Edgar, A.J., Buttery, L.D.K., Hench, L.L., and Polak, J.M., Ionic Products of Bioactive Glass Dissolution Increase Proliferation of Human Osteoblasts and Induce Insulin-like Growth Factor II mRNA Expression and Protein Synthesis. Biochemical and Biophysical Research Communications, 2000 September 24; 276(2): 461-5.22 - Anker et al, Ultraporous Beta-Tricalcium Phosphate is Well Incorporated in Small Cavitary Defects. Clinical Orthopaedics and Related Research, 2005 May; 434: 251-7.23 - Brown, LS, Darmoc, MM, Owsiany, RS, Clineff, TD, Improvements in Healing with a Bioactive Bone Graft Substitute in a Canine Metaphyseal Defect. 55th Annual Meeting of the Orthopaedic Research Society, 2009.24 - Havener, MB, Clineff, TD, Darmoc, MM, Brown, LS, Owsiany, R, A Comparative Study of Synthetic Bone Graft Substitutes in a Canine Metaphyseal Defect. 54th Annual Meeting of the Orthopaedic Research Society, 2008.25 - Marx, J., Bone Marrow: A Validated Biological Driver for Bone Regeneration, White Paper. 26 - Muschler, G.F., Nakamoto, C., Griffith, L.G., Engineering Principles of Clinical Cell-Based Tissue Engineering. Journal of Bone and Joint Surgery, 2004; 86(7): 1541.27 - Curylo, L.J., et al., Augmentation of Spinal Arthrodesis With Autologous Bone Marrow in a Rabbit Posterolateral Spine Fusion Model. Spine, 1999 March 1, 24(5 ): 434-8.28 - Deakin, D.E., Bannister, G.C., Graft Incorporation After Acetabular and Femoral Impaction Grafting With Washed Irradiated Allograft and Autologous Marrow. The Journal of Arthroplasty, 2007 January; 22(1): 89-94.29 - Kim, K.J., et al., Effect of Bone Marrow Grafting on the Titanium Porous-Coated Implant in Bilateral Total Knee Arthroplasty. Acta Orthopaedica, 2007 February; 78(1): 116-22.

    A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particularproduct when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons betrained in the use of any particular product before using it in surgery. The information presented in this brochure isintended to demonstrate a Stryker product. Always refer to the package insert, product label and/or user instructionsbefore using any Stryker product. Products may not be available in all markets. Product availability is subject to theregulatory or medical practices that govern individual markets. Please contact your Stryker representative if you havequestions about the availability of Stryker products in your area.

    Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarksor service marks: Imbibe, Stryker, Vitoss. All other trademarks are trademarks of their respective owners or holders.

    Literature Number: 5701-0000 Rev. 00AQ/LW 08/11

    Copyright 2011 StrykerPrinted in USA

    Num

    ber o

    f Bon

    e G

    raft

    Pro

    duct

    s

    Year

    200180160140120100806040200

    1996

    1997

    1998

    1999

    2000

    2001

    2002

    2003

    2004

    2005

    2006

    2007

    EMS Equipment

    Patient Handling Equipment

    Imaging

    Communications

    Endoscopy

    Navigation

    Interventional Spine

    Neuro & ENT

    Surgical Products

    Orthobiologics

    Spine

    Craniomaxillofacial

    Trauma, Extremities, Deformities

    Joint Replacements

  • The Gold Standard2

    VITOSS is FDA cleared for use in the pelvis,the extremities, and posterolateral spine.

    BMA Harvesting Sites

    What makes Iliac Crest Bone Graft (ICBG) the gold standard?

    Bone marrow can easily be aspirated from several anatomical locations throughout thebody. VITOSS can be used with or without bone marrow aspirate.

    Autograft (ICBG) VITOSS and BMA

    Signal

    Cells

    Scaffold

    VITOSS + BMA = synthetic autograft

    VITOSS + BMA resembles ICBG, thegold standard, in that it has the same

    three components: SCAFFOLD,CELLS, and SIGNALS.3

    Iliac Crest Bone Graft (ICBG) has a Calcium Phosphate(CaP) surface with an open, inter-connected structurethat serves as a scaffold.

    ScaffoldScaffold

    Cells & SignalsCells & Signals

    Bone marrow is a biologic driver found in ICBG.

    ICBG contains bone marrow rich withmesenchymal stem cells and hematopoeticstem cells that facilitate bone regenerationand neo-vascularization. In addition, ICBGprovides signals that help drive bone formation.

    Iliac Crest (PSIS, ASIS) Calcaneus

    Vertebral Body(via pedicle)

    Evidence Based Medicine

    The #1 Synthetic Bone Graft1

    The Cumulative Number of Bone Graft Products 510(k) Cleared4

    Currently, there are over 180 510(k) clearances for orthopaedic bone graftproducts. Because of the vast number of products available, it is oftendifficult for surgeons to assess the best choices for bone grafting.5

    Epstein, N.E., An Analysis of Noninstrumented Posterolateral Lumbar Fusions Performedin Predominantly Geriatric Patients Using Lamina Autograft and Beta-Tricalcium Phos-phate. The Spine Journal, February 2008.Study Design:Prospective; 60 patients using Noninstrumented PLF; Average age = 70 yearsOutcome Measures:CT scans - Fusion assessment; Dynamic X-rays; Fusion assessed separately by 2 neuro-radiologists blinded to the treatment; Post-operative outcomes using SF-36; 3, 6, 12, and24 months follow upResults:Successful fusion in 85% of patients (51/60) when judged by CT and F/E

    Epstein, N.E., Beta-Tricalcium Phosphate: Observation of Use in 100 PosterolateralLumbar Instrumented Fusions. The Spine Journal, June 2009.Study Design:Prospective; 100 patients with lumbar spinal stenosis; Multisegment laminectomies (avg. 3.6segments) and one segment (78 patients) or two segment (22 patients) instrumented PLFOutcome Measures:Dynamic X-rays; 2D-CT Scans; Post-operative outcomes using SF-36; Fusion assessedseparately by 2 neuroradiologists blinded to the treatment; 3, 4.5, 6, and 12 month followup with a minimum of 2.5 years and maximum of 5.0 years (avg. 3.1 years)Results:Successful fusion in 95% of patients (95/100) when judged by CT and Dynamic X-ray

    VITOSS continues to be the #1 Synthetic Bone Graft for the simplest ofreasons...IT WORKS and has HUMAN CLINICAL DATA to support its efficacy.

    Clinical Experience - Over 375,000 implantations worldwide6

    Clinical Proof - Numerous human clinical studies (including pro-spective and peer reviewed) demonstrating VITOSS with autologousbone marrow is an effective autograft replacement.7

    The vast majority of products have no human clinical data to support their use.5

    Ultimately, human clinical data should be used to select a bone graft.

    The #1 SyntheticBone Graft1

    45 Great Valley ParkwayMalvern, PA 193551.888.774.8870 (tel)1.610.640.2603 (fax)

    www.stryker.com

    1 - Millennium Research Group: US Markets for Orthopedic Biomaterials 2010. 2 - Peter Ullrich Jr., Autograft: The Patient's Own Bone. Published in 9/8/99 and updated on 11/25/09 on Spine Universe. 3 - Bellincampi, L., Clineff, T., Erbe, E., Osteoinductivity of Vitoss with Isologous Bone Marrow in Urist Rat Pouch Model. Society for Biomaterials, Tampa, FL, April 24-27, 2002 (Podium). 4 - www.fda.gov, MQV products, November 2007. 5 - The Evolving Role of Bone Graft Substitutes. American Academy of Orthopaedic Surgeons 77th Annual Meeting, March 9-13, 2010. 6 - Stryker Orthobiologics Internal Sales Data, July 2011. 7 - Vitoss Bibliography, P/N 5606-0117 Rev. 00, 2010. 8 - Motomiya, M., et al., Effect of Hydroxyapatite Porous Characteristics on Healing Outcomes in Rabbit Posterolateral Spinal Fusion Model. European Spine Journal, 2007; 16: 2215-2224. 9 - Orthovita Test Report P/N 1070-0008R.10 - Orthovita Test Report P/N 1050-0003R.11 - Characteristics of Vitoss BA Product.12 - Hench, L.L., Splinter, R.J., and Allen, W.C., Bonding Mechanisms at the Interface of Ceramic Prosthetic Materials. Journal of Biomedical Materials Research, 1971; 2(1): 117-141.13 - Hench, L.L., Paschall, H.A., Direct Chemical Bond of Bioactive Glass-Ceramic Materials to Bone and Muscle. Journal of Biomedical Materials Research, 1973; 4: 25-42.14 - Gross, U., The Interface of Various Glasses and Glass Ceramics with a Bony Implantation Bed. Journal of Biomedical Materials Research, 1985; 19: 251-271.15 - Sanders, D.M., Hench, L.L., Mechanisms of Glass Corrosion. Journal of American Ceramic Society. 1973; 56(7): 373-377.16 - Hench, L.L., Characterization of Glass Corrosion and Durability. Journal of Non-Crystalline Solids, 1975; 19: 27-39.17 - Ogino, M., Hench, L.L., Formation of Calcium Phosphate Films on Silicate Glasses. Journal of Non-Crystalline Solids, 1980; 38 and 39: 673-678.18 - Vrouwenvelder, W.C.A., Histological and Biochemical Evaluation of Osteoblasts Cultured on Bioactive Glass, Hydroxyapatite, Titanium Alloy, and Stainless Steel. Journal of Biomedical Materials Research, 1993 Apr; 27(4): 465-75.19 - Hench, L.L., The Story of Bioglass. Journal of Materials Science: Materials in Medicine, 2006 Nov; 17(11): 967-78.20 - Oonishi, H., et al., Particulate Bioglass Compared with Hydroxyapatite as a Bone Graft Substitute. Clinical Orthopaedics and Related Research, 1997 Jan; 334: 316-25.21 - Xynos, I.D., Edgar, A.J., Buttery, L.D.K., Hench, L.L., and Polak, J.M., Ionic Products of Bioactive Glass Dissolution Increase Proliferation of Human Osteoblasts and Induce Insulin-like Growth Factor II mRNA Expression and Protein Synthesis. Biochemical and Biophysical Research Communications, 2000 September 24; 276(2): 461-5.22 - Anker et al, Ultraporous Beta-Tricalcium Phosphate is Well Incorporated in Small Cavitary Defects. Clinical Orthopaedics and Related Research, 2005 May; 434: 251-7.23 - Brown, LS, Darmoc, MM, Owsiany, RS, Clineff, TD, Improvements in Healing with a Bioactive Bone Graft Substitute in a Canine Metaphyseal Defect. 55th Annual Meeting of the Orthopaedic Research Society, 2009.24 - Havener, MB, Clineff, TD, Darmoc, MM, Brown, LS, Owsiany, R, A Comparative Study of Synthetic Bone Graft Substitutes in a Canine Metaphyseal Defect. 54th Annual Meeting of the Orthopaedic Research Society, 2008.25 - Marx, J., Bone Marrow: A Validated Biological Driver for Bone Regeneration, White Paper. 26 - Muschler, G.F., Nakamoto, C., Griffith, L.G., Engineering Principles of Clinical Cell-Based Tissue Engineering. Journal of Bone and Joint Surgery, 2004; 86(7): 1541.27 - Curylo, L.J., et al., Augmentation of Spinal Arthrodesis With Autologous Bone Marrow in a Rabbit Posterolateral Spine Fusion Model. Spine, 1999 March 1, 24(5 ): 434-8.28 - Deakin, D.E., Bannister, G.C., Graft Incorporation After Acetabular and Femoral Impaction Grafting With Washed Irradiated Allograft and Autologous Marrow. The Journal of Arthroplasty, 2007 January; 22(1): 89-94.29 - Kim, K.J., et al., Effect of Bone Marrow Grafting on the Titanium Porous-Coated Implant in Bilateral Total Knee Arthroplasty. Acta Orthopaedica, 2007 February; 78(1): 116-22.

    A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particularproduct when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons betrained in the use of any particular product before using it in surgery. The information presented in this brochure isintended to demonstrate a Stryker product. Always refer to the package insert, product label and/or user instructionsbefore using any Stryker product. Products may not be available in all markets. Product availability is subject to theregulatory or medical practices that govern individual markets. Please contact your Stryker representative if you havequestions about the availability of Stryker products in your area.

    Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarksor service marks: Imbibe, Stryker, Vitoss. All other trademarks are trademarks of their respective owners or holders.

    Literature Number: 5701-0000 Rev. 00AQ/LW 08/11

    Copyright 2011 StrykerPrinted in USA

    Num

    ber o

    f Bon

    e G

    raft

    Pro

    duct

    sYear

    200180160140120100806040200

    1996

    1997

    1998

    1999

    2000

    2001

    2002

    2003

    2004

    2005

    2006

    2007

    EMS Equipment

    Patient Handling Equipment

    Imaging

    Communications

    Endoscopy

    Navigation

    Interventional Spine

    Neuro & ENT

    Surgical Products

    Orthobiologics

    Spine

    Craniomaxillofacial

    Trauma, Extremities, Deformities

    Joint Replacements

  • The VITOSS Advantage Not All Scaffolds are Created Equal

    Bone Marrow - A Validated Biologic Driver25

    VITOSS Product Portfolio

    VITOSS BA has a unique porosity, structure, bioactivity, and chemistry to drive the 3-Dregeneration of bone and potentially increase the rate of healing as shown in an animal study.23

    There are over 150 references supporting the use of bone marrow for grafting.25

    Less morbidity

    BMA enhances fusion over ICBG alone

    BMA enhances graft incorporation

    BMA is a safe alternative to iliac crest harvest without associated complicationsor morbidity. 900(+) patients with bone marrow aspiration (16-200mL) showedno infection, no hematoma, no chronic pain, and only 2 bruises.26

    A pre-clinical evaluation (posterolateral fusion) showed 61% fusion inICBG + BMA versus 25% fusion in ICBG + blood at 12 weeks.27

    90% incorporation of graft with BMA was achieved during impaction graftingversus 40% for controls (historical).The addition of autologous marrow is a cheap and highly effective way ofachieving graft incorporation.28

    There was a statistically significant decrease in radioluscent lines on x-rays ofknees grafted with marrow versus those without.Iliac marrow is useful as a bone grafting material to enhance the biologicalformation in porous coated implants.29

    Why are porosity, structure, bioactivity, and chemistry important?

    porosity

    structure

    chemistry

    Only materials with interconnected porosity will allowfor 3-D regeneration of bone as opposed to creepingsubstitution. Additionally, increased porosity has beenshown to lead to higher fusion rates.8 VITOSS is a highlyporous calcium-phosphate (up to 90% porous).9

    Despite having similar chemistries, manyproducts perform differently due to differentstructure. VITOSS has an open-interconnectedstructure that facilitates 3-D bone regeneration.10

    bioactivity11Bioactive glass has shown positive bonding-to-bone properties.12-14 Upon implantation, theionic constituents (Si+, Na+, Ca2+) of bioactiveglass are released into the surrounding environ-ment and react with the bodily fluids.18-21 Thisreaction produces the deposition of a thin layerof physiologic CaP at its surface, thus attractingosteoblasts to the layer to create a matrix thatpromotes an osteostimulatory effect.12-18 This maylead to the bonding of new bone to the scaffold.

    Chemistry affects the rate of resorption. Bone grafts should resorb asnew bone forms in a physiologic time frame. VITOSS is composed of-TCP and is stable at physiologic pH. It resorbs during the naturalremodeling process of bone. Evidence suggests that -TCP resorbsin the most relevant time frame.22

    VITOSS

    ActiFuse

    ProOsteon

    MasterGraft

    3 Weeks 6 Weeks 12 Weeks 24 Weeks 52 Weeks

    Comparison of VITOSS to ActiFuse, ProOsteon, and MasterGraft in a canine metaphyseal study in order to radiologically comparehealing at 3, 6, 12, 24, and 52 weeks. A 10mm x 22mm drill defect was created in the proximal humerus and lled with 2cc of bone graft.24

    VITOSS

    sponge

    golf ball

    otherscaffolds

    MorselsVitoss Morsels and Blocks are aneconomical way to provide a qualitysynthetic product to your patients forlarge volume grafting applications.Vitoss Morsels offer a cost compara-tive option to allograft chips.

    15cc Macro (2102-0020)

    30cc Macro(2102-0021)

    1.2cc Blocks(2102-0013)

    10cc Blocks(2102-0006)

    30cc Macro (x10)(2102-0131)

    Foam Pack*Vitoss Foam Pack is a versatile materialthat is stable in a uid environment, cansoak and hold bone marrow, is com-pression-resistant, and can be mixedwith local bone to form a composite.* Also available in Vitoss BA and BA2X

    * Also available in Vitoss BA

    1.2cc(2102-1401)(2102-1601) BA(2102-2101) BA2X

    2.5cc(2102-1402)(2102-1602) BA(2102-2102) BA

    5cc(2102-1405)(2102-1605) BA(2102-2105) BA

    10cc(2102-1410)(2102-1610) BA(2102-2110) BA

    Foam FlowVitoss Foam Flow can be percu-taneously injected into containedbone defects, providing an evenll of graft material. Foam Flow isexcellent for lling bone cysts.

    5cc(2102-1305)

    10cc(2102-1310)

    CanistersVitoss Canisters offer the handling and deliveryof Vitoss Morsels with the use of bone marrowaspirate or blood. It is a closed system design-ed to minimize handling and exposure to po-tential contaminants.

    5cc Micro(2102-0026)

    5cc Standard(2102-0030)

    10cc Micro(2102-0027)

    10cc Standard(2102-0031)

    15cc Micro(2102-0028)

    15cc Standard(2102-0032)

    30cc Micro(2102-0029)

    30cc Standard(2102-0033)

    Foam Strip*Vitoss Foam Strip is a compression re-sistant pre-formed strip that is exiblewhen wet, can soak and hold bonemarrow, and is easily customized forvarious grafting applications.

    25 x 100 x 4mm10cc (2102-1100)25 x 100 x 4mm (BA)10cc (2102-1500)

    25 x 100 x 8mm20cc (2102-1120)25 x 100 x 8mm (BA)20cc (2102-1520)

    25 x 240 x 4mm24cc (2102-1101)

    25 x 50 x 4mm5cc (2102-1105)25 x 50 x 4mm (BA)5cc (2102-1505)

    25 x 50 x 8mm10cc (2102-1110)25 x 50 x 8mm (BA)10cc (2102-1510)

    75 x 100 x 4mm30cc (2102-1130)

    CupsVitoss Cups are synthetic bone graft implantsthat are designed to simplify the grafting processin reconstruction procedures. The shapes arepre-contoured to facilitate placement into thebony area and provide graft containment.

    56mm (Int. Dia.) Cup23cc (2102-1056)

    ImbibeImbibe is a system of disposableproducts from syringes to nee-dles to graft delivery devices.The syringes have a uniquescrew off cap to allow for a largerow. The Imbibe bone marrowaspiration needles provide a minimally invasive way toharvest stem cells contained in bone marrow. Theseneedles come with both bullet-tip and sharp-trocarstylets, which are color coded to distinguish eachneedle. The graft delivery tools can be used todeliver Vitoss in a minimally invasive application.

    Syringes

    10cc(2105-0010)

    20cc(2105-0020)

    30cc(2105-0030)

    Needles

    11 gauge x 4 inch(2090-0027)

    11 gauge x 6 inch(2090-0028)

    8 gauge x 6 inch(2090-0029)

    8 gauge x 8 inch(2090-0047)

    Fenestrated8 gauge x 6 inch(2090-0030)

    Bullet-tip Sharp-tip

  • The VITOSS Advantage Not All Scaffolds are Created Equal

    Bone Marrow - A Validated Biologic Driver25

    VITOSS Product Portfolio

    VITOSS BA has a unique porosity, structure, bioactivity, and chemistry to drive the 3-Dregeneration of bone and potentially increase the rate of healing as shown in an animal study.23

    There are over 150 references supporting the use of bone marrow for grafting.25

    Less morbidity

    BMA enhances fusion over ICBG alone

    BMA enhances graft incorporation

    BMA is a safe alternative to iliac crest harvest without associated complicationsor morbidity. 900(+) patients with bone marrow aspiration (16-200mL) showedno infection, no hematoma, no chronic pain, and only 2 bruises.26

    A pre-clinical evaluation (posterolateral fusion) showed 61% fusion inICBG + BMA versus 25% fusion in ICBG + blood at 12 weeks.27

    90% incorporation of graft with BMA was achieved during impaction graftingversus 40% for controls (historical).The addition of autologous marrow is a cheap and highly effective way ofachieving graft incorporation.28

    There was a statistically significant decrease in radioluscent lines on x-rays ofknees grafted with marrow versus those without.Iliac marrow is useful as a bone grafting material to enhance the biologicalformation in porous coated implants.29

    Why are porosity, structure, bioactivity, and chemistry important?

    porosity

    structure

    chemistry

    Only materials with interconnected porosity will allowfor 3-D regeneration of bone as opposed to creepingsubstitution. Additionally, increased porosity has beenshown to lead to higher fusion rates.8 VITOSS is a highlyporous calcium-phosphate (up to 90% porous).9

    Despite having similar chemistries, manyproducts perform differently due to differentstructure. VITOSS has an open-interconnectedstructure that facilitates 3-D bone regeneration.10

    bioactivity11Bioactive glass has shown positive bonding-to-bone properties.12-14 Upon implantation, theionic constituents (Si+, Na+, Ca2+) of bioactiveglass are released into the surrounding environ-ment and react with the bodily fluids.18-21 Thisreaction produces the deposition of a thin layerof physiologic CaP at its surface, thus attractingosteoblasts to the layer to create a matrix thatpromotes an osteostimulatory effect.12-18 This maylead to the bonding of new bone to the scaffold.

    Chemistry affects the rate of resorption. Bone grafts should resorb asnew bone forms in a physiologic time frame. VITOSS is composed of-TCP and is stable at physiologic pH. It resorbs during the naturalremodeling process of bone. Evidence suggests that -TCP resorbsin the most relevant time frame.22

    VITOSS

    ActiFuse

    ProOsteon

    MasterGraft

    3 Weeks 6 Weeks 12 Weeks 24 Weeks 52 Weeks

    Comparison of VITOSS to ActiFuse, ProOsteon, and MasterGraft in a canine metaphyseal study in order to radiologically comparehealing at 3, 6, 12, 24, and 52 weeks. A 10mm x 22mm drill defect was created in the proximal humerus and lled with 2cc of bone graft.24

    VITOSS

    sponge

    golf ball

    otherscaffolds

    MorselsVitoss Morsels and Blocks are aneconomical way to provide a qualitysynthetic product to your patients forlarge volume grafting applications.Vitoss Morsels offer a cost compara-tive option to allograft chips.

    15cc Macro (2102-0020)

    30cc Macro(2102-0021)

    1.2cc Blocks(2102-0013)

    10cc Blocks(2102-0006)

    30cc Macro (x10)(2102-0131)

    Foam Pack*Vitoss Foam Pack is a versatile materialthat is stable in a uid environment, cansoak and hold bone marrow, is com-pression-resistant, and can be mixedwith local bone to form a composite.* Also available in Vitoss BA and BA2X

    * Also available in Vitoss BA

    1.2cc(2102-1401)(2102-1601) BA(2102-2101) BA2X

    2.5cc(2102-1402)(2102-1602) BA(2102-2102) BA

    5cc(2102-1405)(2102-1605) BA(2102-2105) BA

    10cc(2102-1410)(2102-1610) BA(2102-2110) BA

    Foam FlowVitoss Foam Flow can be percu-taneously injected into containedbone defects, providing an evenll of graft material. Foam Flow isexcellent for lling bone cysts.

    5cc(2102-1305)

    10cc(2102-1310)

    CanistersVitoss Canisters offer the handling and deliveryof Vitoss Morsels with the use of bone marrowaspirate or blood. It is a closed system design-ed to minimize handling and exposure to po-tential contaminants.

    5cc Micro(2102-0026)

    5cc Standard(2102-0030)

    10cc Micro(2102-0027)

    10cc Standard(2102-0031)

    15cc Micro(2102-0028)

    15cc Standard(2102-0032)

    30cc Micro(2102-0029)

    30cc Standard(2102-0033)

    Foam Strip*Vitoss Foam Strip is a compression re-sistant pre-formed strip that is exiblewhen wet, can soak and hold bonemarrow, and is easily customized forvarious grafting applications.

    25 x 100 x 4mm10cc (2102-1100)25 x 100 x 4mm (BA)10cc (2102-1500)

    25 x 100 x 8mm20cc (2102-1120)25 x 100 x 8mm (BA)20cc (2102-1520)

    25 x 240 x 4mm24cc (2102-1101)

    25 x 50 x 4mm5cc (2102-1105)25 x 50 x 4mm (BA)5cc (2102-1505)

    25 x 50 x 8mm10cc (2102-1110)25 x 50 x 8mm (BA)10cc (2102-1510)

    75 x 100 x 4mm30cc (2102-1130)

    CupsVitoss Cups are synthetic bone graft implantsthat are designed to simplify the grafting processin reconstruction procedures. The shapes arepre-contoured to facilitate placement into thebony area and provide graft containment.

    56mm (Int. Dia.) Cup23cc (2102-1056)

    ImbibeImbibe is a system of disposableproducts from syringes to nee-dles to graft delivery devices.The syringes have a uniquescrew off cap to allow for a largerow. The Imbibe bone marrowaspiration needles provide a minimally invasive way toharvest stem cells contained in bone marrow. Theseneedles come with both bullet-tip and sharp-trocarstylets, which are color coded to distinguish eachneedle. The graft delivery tools can be used todeliver Vitoss in a minimally invasive application.

    Syringes

    10cc(2105-0010)

    20cc(2105-0020)

    30cc(2105-0030)

    Needles

    11 gauge x 4 inch(2090-0027)

    11 gauge x 6 inch(2090-0028)

    8 gauge x 6 inch(2090-0029)

    8 gauge x 8 inch(2090-0047)

    Fenestrated8 gauge x 6 inch(2090-0030)

    Bullet-tip Sharp-tip

  • The VITOSS Advantage Not All Scaffolds are Created Equal

    Bone Marrow - A Validated Biologic Driver25

    VITOSS Product Portfolio

    VITOSS has a unique porosity, structure, bioactivity, and chemistry to drivethe 3-D regeneration of bone and potentially increase the rate of healing.23

    There are over 175 references supporting the use of bone marrow for grafting.25

    Less/no morbidity

    BMA enhances fusion over ICBG alone

    BMA enhances graft incorporation

    BMA is a safe alternative to iliac crest harvest without associated complicationsor morbidity. 900(+) patients with bone marrow aspiration (16-200mL) showedno infection, no hematoma, no chronic pain, and only 2 bruises.26

    A pre-clinical evaluation (posterolateral fusion) showed 61% fusion inICBG + BMA versus 25% fusion in ICBG + blood at 12 weeks.27

    90% incorporation of graft with BMA was achieved during impaction graftingversus 40% for controls (historical).The addition of autologous marrow is a cheap and highly effective way ofachieving graft incorporation.28

    There was a statistically significant decrease in radioluscent lines on x-rays ofknees grafted with marrow versus those without.Iliac marrow is useful as a bone grafting material to enhance the biologicalformation in porous coated implants.29

    Why are porosity, structure, bioactivity, and chemistry important?

    porosity

    structure

    chemistry

    Only materials with interconnected porosity will allowfor 3-D regeneration of bone as opposed to creepingsubstitution. Additionally, increased porosity has beenshown to lead to higher fusion rates.8 VITOSS is a highlyporous calcium-phosphate (up to 90% porous).9

    Despite having similar chemistries, manyproducts perform differently due to differentstructure. VITOSS has an open-interconnectedstructure that facilitates 3-D bone regeneration.10

    bioactivity11Bioactive glass has shown positive bonding-to-bone properties.12-14 Upon implantation, theionic constituents (Si+, Na+, Ca2+) of bioactiveglass are released into the surrounding environ-ment and react with the bodily fluids.18-21 Thisreaction produces the deposition of a thin layerof physiologic CaP at its surface, thus attractingosteoblasts to the layer to create a matrix thatpromotes an osteostimulatory effect.12-18 This maylead to the bonding of new bone to the scaffold.

    Chemistry affects the rate of resorption. Bone grafts should resorb asnew bone forms in a physiologic time frame. VITOSS is composed of-TCP and is stable at physiologic pH. It resorbs during the naturalremodeling process of bone. Evidence suggests that -TCP resorbsin the most relevant time frame.22

    VITOSSTM

    ActiFuse

    ProOsteon

    MasterGraft

    3 Weeks 6 Weeks 12 Weeks 24 Weeks 52 Weeks

    Comparison of VITOSS to ActiFuse, ProOsteon, and MasterGraft in a canine metaphyseal study in order to radiologically comparehealing at 3, 6, 12, 24, and 52 weeks. A 10mm x 22mm drill defect was created in the proximal humerus and lled with 2cc of bone graft.24

    VITOSS

    sponge

    golf ball

    otherscaffolds

    MorselsVitoss Morsels and Blocks are aneconomical way to provide a qualitysynthetic product to your patients forlarge volume grafting applications.Vitoss Morsels offer a cost compara-tive option to allograft chips.

    15cc Macro (2102-0020)

    30cc Macro(2102-0021)

    1.2cc Blocks(2102-0013)

    10cc Blocks(2102-0006)

    30cc Macro (x10)(2102-0131)

    Foam Pack*Vitoss Foam Pack is a versatile materialthat is stable in a uid environment, cansoak and hold bone marrow, is com-pression-resistant, and can be mixedwith local bone to form a composite.* Also available in Vitoss BA and BA2X

    * Also available in Vitoss BA

    1.2cc(2102-1401)(2102-1601) BA(2102-2101) BA2X

    2.5cc(2102-1402)(2102-1602) BA(2102-2102) BA

    5cc(2102-1405)(2102-1605) BA(2102-2105) BA

    10cc(2102-1410)(2102-1610) BA(2102-2110) BA

    Foam FlowVitoss Foam Flow can be percu-taneously injected into containedbone defects, providing an evenll of graft material. Foam Flow isexcellent for lling bone cysts.

    5cc(2102-1305)

    10cc(2102-1310)

    CanistersVitoss Canisters offer the handling and deliveryof Vitoss Morsels with the use of bone marrowaspirate or blood. It is a closed system design-ed to minimize handling and exposure to po-tential contaminants.

    5cc Micro(2102-0026)

    5cc Standard(2102-0030)

    10cc Micro(2102-0027)

    10cc Standard(2102-0031)

    15cc Micro(2102-0028)

    15cc Standard(2102-0032)

    30cc Micro(2102-0029)

    30cc Standard(2102-0033)

    Foam Strip*Vitoss Foam Strip is a compression re-sistant pre-formed strip that is exiblewhen wet, can soak and hold bonemarrow, and is easily customized forvarious grafting applications.

    25 x 100 x 4mm10cc (2102-1100)25 x 100 x 4mm (BA)10cc (2102-1500)

    25 x 100 x 8mm20cc (2102-1120)25 x 100 x 8mm (BA)20cc (2102-1520)

    25 x 240 x 4mm24cc (2102-1101)

    25 x 50 x 4mm5cc (2102-1105)25 x 50 x 4mm (BA)5cc (2102-1505)

    25 x 50 x 8mm10cc (2102-1110)25 x 50 x 8mm (BA)10cc (2102-1510)

    75 x 100 x 4mm30cc (2102-1130)

    CupsVitoss Cups are synthetic bone graft implantsthat are designed to simplify the grafting processin reconstruction procedures. The shapes arepre-contoured to facilitate placement into thebony area and provide graft containment.

    56mm (Int. Dia.) Cup23cc (2102-1056)

    ImbibeImbibe is a system of disposableproducts from syringes to nee-dles to graft delivery devices.The syringes have a uniquescrew off cap to allow for a largerow. The Imbibe bone marrowaspiration needles provide a minimally invasive way toharvest stem cells contained in bone marrow. Theseneedles come with both bullet-tip and sharp-trocarstylets, which are color coded to distinguish eachneedle. The graft delivery tools can be used todeliver Vitoss in a minimally invasive application.

    Syringes

    10cc(2105-0010)

    20cc(2105-0020)

    30cc(2105-0030)

    Needles

    11 gauge x 4 inch(2090-0027)

    11 gauge x 6 inch(2090-0028)

    8 gauge x 6 inch(2090-0029)

    8 gauge x 8 inch(2090-0047)

    Fenestrated8 gauge x 6 inch(2090-0030)

    Bullet-tip Sharp-tip

  • The VITOSS Advantage Not All Scaffolds are Created Equal

    Bone Marrow - A Validated Biologic Driver25

    VITOSS Product Portfolio

    VITOSS has a unique porosity, structure, bioactivity, and chemistry to drivethe 3-D regeneration of bone and potentially increase the rate of healing.23

    There are over 175 references supporting the use of bone marrow for grafting.25

    Less/no morbidity

    BMA enhances fusion over ICBG alone

    BMA enhances graft incorporation

    BMA is a safe alternative to iliac crest harvest without associated complicationsor morbidity. 900(+) patients with bone marrow aspiration (16-200mL) showedno infection, no hematoma, no chronic pain, and only 2 bruises.26

    A pre-clinical evaluation (posterolateral fusion) showed 61% fusion inICBG + BMA versus 25% fusion in ICBG + blood at 12 weeks.27

    90% incorporation of graft with BMA was achieved during impaction graftingversus 40% for controls (historical).The addition of autologous marrow is a cheap and highly effective way ofachieving graft incorporation.28

    There was a statistically significant decrease in radioluscent lines on x-rays ofknees grafted with marrow versus those without.Iliac marrow is useful as a bone grafting material to enhance the biologicalformation in porous coated implants.29

    Why are porosity, structure, bioactivity, and chemistry important?

    porosity

    structure

    chemistry

    Only materials with interconnected porosity will allowfor 3-D regeneration of bone as opposed to creepingsubstitution. Additionally, increased porosity has beenshown to lead to higher fusion rates.8 VITOSS is a highlyporous calcium-phosphate (up to 90% porous).9

    Despite having similar chemistries, manyproducts perform differently due to differentstructure. VITOSS has an open-interconnectedstructure that facilitates 3-D bone regeneration.10

    bioactivity11Bioactive glass has shown positive bonding-to-bone properties.12-14 Upon implantation, theionic constituents (Si+, Na+, Ca2+) of bioactiveglass are released into the surrounding environ-ment and react with the bodily fluids.18-21 Thisreaction produces the deposition of a thin layerof physiologic CaP at its surface, thus attractingosteoblasts to the layer to create a matrix thatpromotes an osteostimulatory effect.12-18 This maylead to the bonding of new bone to the scaffold.

    Chemistry affects the rate of resorption. Bone grafts should resorb asnew bone forms in a physiologic time frame. VITOSS is composed of-TCP and is stable at physiologic pH. It resorbs during the naturalremodeling process of bone. Evidence suggests that -TCP resorbsin the most relevant time frame.22

    VITOSSTM

    ActiFuse

    ProOsteon

    MasterGraft

    3 Weeks 6 Weeks 12 Weeks 24 Weeks 52 Weeks

    Comparison of VITOSS to ActiFuse, ProOsteon, and MasterGraft in a canine metaphyseal study in order to radiologically comparehealing at 3, 6, 12, 24, and 52 weeks. A 10mm x 22mm drill defect was created in the proximal humerus and lled with 2cc of bone graft.24

    VITOSS

    sponge

    golf ball

    otherscaffolds

    MorselsVitoss Morsels and Blocks are aneconomical way to provide a qualitysynthetic product to your patients forlarge volume grafting applications.Vitoss Morsels offer a cost compara-tive option to allograft chips.

    15cc Macro (2102-0020)

    30cc Macro(2102-0021)

    1.2cc Blocks(2102-0013)

    10cc Blocks(2102-0006)

    30cc Macro (x10)(2102-0131)

    Foam Pack*Vitoss Foam Pack is a versatile materialthat is stable in a uid environment, cansoak and hold bone marrow, is com-pression-resistant, and can be mixedwith local bone to form a composite.* Also available in Vitoss BA and BA2X

    * Also available in Vitoss BA

    1.2cc(2102-1401)(2102-1601) BA(2102-2101) BA2X

    2.5cc(2102-1402)(2102-1602) BA(2102-2102) BA

    5cc(2102-1405)(2102-1605) BA(2102-2105) BA

    10cc(2102-1410)(2102-1610) BA(2102-2110) BA

    Foam FlowVitoss Foam Flow can be percu-taneously injected into containedbone defects, providing an evenll of graft material. Foam Flow isexcellent for lling bone cysts.

    5cc(2102-1305)

    10cc(2102-1310)

    CanistersVitoss Canisters offer the handling and deliveryof Vitoss Morsels with the use of bone marrowaspirate or blood. It is a closed system design-ed to minimize handling and exposure to po-tential contaminants.

    5cc Micro(2102-0026)

    5cc Standard(2102-0030)

    10cc Micro(2102-0027)

    10cc Standard(2102-0031)

    15cc Micro(2102-0028)

    15cc Standard(2102-0032)

    30cc Micro(2102-0029)

    30cc Standard(2102-0033)

    Foam Strip*Vitoss Foam Strip is a compression re-sistant pre-formed strip that is exiblewhen wet, can soak and hold bonemarrow, and is easily customized forvarious grafting applications.

    25 x 100 x 4mm10cc (2102-1100)25 x 100 x 4mm (BA)10cc (2102-1500)

    25 x 100 x 8mm20cc (2102-1120)25 x 100 x 8mm (BA)20cc (2102-1520)

    25 x 240 x 4mm24cc (2102-1101)

    25 x 50 x 4mm5cc (2102-1105)25 x 50 x 4mm (BA)5cc (2102-1505)

    25 x 50 x 8mm10cc (2102-1110)25 x 50 x 8mm (BA)10cc (2102-1510)

    75 x 100 x 4mm30cc (2102-1130)

    CupsVitoss Cups are synthetic bone graft implantsthat are designed to simplify the grafting processin reconstruction procedures. The shapes arepre-contoured to facilitate placement into thebony area and provide graft containment.

    56mm (Int. Dia.) Cup23cc (2102-1056)

    ImbibeImbibe is a system of disposableproducts from syringes to nee-dles to graft delivery devices.The syringes have a uniquescrew off cap to allow for a largerow. The Imbibe bone marrowaspiration needles provide a minimally invasive way toharvest stem cells contained in bone marrow. Theseneedles come with both bullet-tip and sharp-trocarstylets, which are color coded to distinguish eachneedle. The graft delivery tools can be used todeliver Vitoss in a minimally invasive application.

    Syringes

    10cc(2105-0010)

    20cc(2105-0020)

    30cc(2105-0030)

    Needles

    11 gauge x 4 inch(2090-0027)

    11 gauge x 6 inch(2090-0028)

    8 gauge x 6 inch(2090-0029)

    8 gauge x 8 inch(2090-0047)

    Fenestrated8 gauge x 6 inch(2090-0030)

    Bullet-tip Sharp-tip

  • The Gold Standard2

    VITOSS is FDA cleared for use in the pelvis,the extremities, and posterolateral spine.

    BMA Harvesting Sites

    What makes Iliac Crest Bone Graft (ICBG) the gold standard?

    Bone marrow can easily be aspirated from several anatomical locations throughout thebody. VITOSS can be used with or without bone marrow aspirate.

    Autograft (ICBG) VITOSS and BMA

    Signal

    Cells

    Scaffold

    VITOSS + BMA = synthetic autograft

    VITOSS resembles ICBG, the goldstandard, in that it has the samethree components: SCAFFOLD,

    CELLS, and SIGNALS.3

    Iliac Crest Bone Graft (ICBG) has a Calcium Phosphate(CaP) surface with an open, inter-connected structurethat serves as a scaffold.

    ScaffoldScaffold

    Cells & SignalsCells & Signals

    Bone marrow is a biologic driver found in ICBG.

    ICBG contains bone marrow rich withmesenchymal stem cells and hematopoeticstem cells that facilitate bone regenerationand neo-vascularization. In addition, ICBGprovides signals that help drive bone formation.

    Iliac Crest (PSIS, ASIS) Calcaneus

    Vertebral Body(via pedicle)

    Evidence Based Medicine

    The #1 Synthetic Bone Graft1

    The Cumulative Number of Bone Graft Products 510(k) Cleared4

    Currently, there are over 180 510(k) clearances for orthopaedic bone graftproducts. Because of the vast number of products available, it is oftendifficult for surgeons to assess the best choices for bone grafting.5

    Epstein, N.E., An analysis of Noninstrumented Posterolateral Lunbar Fusions Performedin Predominantly Geriatric Patients Using Lamina Autograft and Beta-Tricalcium Phos-phate. The Spine Journal, February 2008.Study Design:Prospective; 60 patients using Noninstrumented PLF; Average age = 70 yearsOutcome Measures:CT scans - Fusion assessment; Dynamic X-rays; Fusion assessed separately by 2 neuro-radiologists blinded to the treatment; Post-operative outcomes using SF-36; 3, 6, 12, and24 months follow upResults:Successful fusion in 85% of patients (51/60) when judged by CT and F/E

    Epstein, N.E., Beta-Tricalcium Phosphate: Observation of Use in 100 PosterolateralLumbar Instrumented Fusions. The Spine Journal, June 2009.Study Design:Prospective; 100 patients with lumbar spinal stenosis; Multisegment laminectomies (avg. 3.6segments) and one segment (78 patients) or two segment (22 patients) instrumented PLFOutcome Measures:Dynamic X-rays; 2D-CT Scans; Post-operative outcomes using SF-36; Fusion assessedseparately by 2 neuroradiologists blinded to the treatment; 3, 4.5, 6, and 12 month followup with a minimum of 2.5 years and maximum of 5.0 years (avg. 3.1 years)Results:Successful fusion in 95% of patients (95/100) when judged by CT and Dynamic X-ray

    VITOSS continues to be the #1 Synthetic Bone Graft for the simplest ofreasons...IT WORKS and has HUMAN CLINICAL DATA to support its efficacy.

    Clinical Experience - Over 375,000 implantations worldwide6

    Clinical Proof - Numerous human clinical studies (including pro-spective and peer reviewed) demonstrating VITOSS with autologousbone marrow is an effective autograft replacement.7

    The vast majority of products have no human clinical data to support their use.5

    Ultimately, human clinical data should be used to select a bone graft.

    The #1 SyntheticBone Graft1

    45 Great Valley ParkwayMalvern, PA 193551.888.774.8870 (tel)1.610.640.2603 (fax)

    www.stryker.com

    1 - Millennium Research Group: US Markets for Orthopedic Biomaterials 2010. 2 - Peter Ullrich Jr., Autograft: The Patient's Own Bone. Published in 9/8/99 and updated on 11/25/09 on Spine Universe. 3 - Bellincampi, L., Clineff, T., Erbe, E., Osteoinductivity of Vitoss with Isologous Bone Marrow in Urist Rat Pouch Model. Society for Biomaterials, Tampa, FL, April 24-27, 2002 (Podium). 4 - www.fda.gov, MQV products, November 2007. 5 - The Evolving Role of Bone Graft Substitutes. American Academy of Orthopaedic Surgeons 77th Annual Meeting, March 9-13, 2010. 6 - Stryker Orthobiologics Internal Sales Data, July 2011. 7 - Vitoss Bibliography, P/N 5606-0117 Rev. 00, 2010. 8 - Motomiya, M., et al., Effect of Hydroxyapatite Porous Characteristics on Healing Outcomes in Rabbit Posterolateral Spinal Fusion Model. European Spine Journal, 2007; 16: 2215-2224. 9 - Orthovita Test Report P/N 1070-0008R.10 - Orthovita Test Report P/N 1050-0003R.11 - Characteristics of Vitoss BA Product.12 - Hench, L.L., Splinter, R.J., and Allen, W.C., Bonding Mechanisms at the Interface of Ceramic Prosthetic Materials. Journal of Biomedical Materials Research, 1971; 2(1): 117-141.13 - Hench, L.L., Paschall, H.A., Direct Chemical Bond of Bioactive Glass-Ceramic Materials to Bone and Muscle. Journal of Biomedical Materials Research, 1973; 4: 25-42.14 - Gross, U., The Interface of Various Glasses and Glass Ceramics with a Bony Implantation Bed. Journal of Biomedical Materials Research, 1985; 19: 251-271.15 - Sanders, D.M., Hench, L.L., Mechanisms of Glass Corrosion. Journal of American Ceramic Society. 1973; 56(7): 373-377.16 - Hench, L.L., Characterization of Glass Corrosion and Durability. Journal of Non-Crystalline Solids, 1975; 19: 27-39.17 - Ogino, M., Hench, L.L., Formation of Calcium Phosphate Films on Silicate Glasses. Journal of Non-Crystalline Solids, 1980; 38 and 39: 673-678.18 - Vrouwenvelder, W.C.A., Histological and Biochemical Evaluation of Osteoblasts Cultured on Bioactive Glass, Hydroxyapatite, Titanium Alloy, and Stainless Steel. Journal of Biomedical Materials Research, 1993 Apr; 27(4): 465-75.19 - Hench, L.L., The Story of Bioglass. Journal of Materials Science: Materials in Medicine, 2006 Nov; 17(11): 967-78.20 - Oonishi, H., et al., Particulate Bioglass Compared with Hydroxyapatite as a Bone Graft Substitute. Clinical Orthopaedics and Related Research, 1997 Jan; 334: 316-25.21 - Xynos, I.D., Edgar, A.J., Buttery, L.D.K., Hench, L.L., and Polak, J.M., Ionic Products of Bioactive Glass Dissolution Increase Proliferation of Human Osteoblasts and Induce Insulin-like Growth Factor II mRNA Expression and Protein Synthesis. Biochemical and Biophysical Research Communications, 2000 September 24; 276(2): 461-5.22 - Anker et al, Ultraporous Beta-Tricalcium Phosphate is Well Incorporated in Small Cavitary Defects. Clinical Orthopaedics and Related Research, 2005 May; 434: 251-7.23 - Brown, LS, Darmoc, MM, Owsiany, RS, Clineff, TD, Improvements in Healing with a Bioactive Bone Graft Substitute in a Canine Metaphyseal Defect. 55th Annual Meeting of the Orthopaedic Research Society, 2009.24 - Havener, MB, Clineff, TD, Darmoc, MM, Brown, LS, Owsiany, R, A Comparative Study of Synthetic Bone Graft Substitutes in a Canine Metaphyseal Defect. 54th Annual Meeting of the Orthopaedic Research Society, 2008.25 - Marx, J., Bone Marrow: A Validated Biological Driver for Bone Regeneration, White Paper. 26 - Muschler, G.F., Nakamoto, C., Griffith, L.G., Engineering Principles of Clinical Cell-Based Tissue Engineering. Journal of Bone and Joint Surgery, 2004; 86(7): 1541.27 - Curylo, L.J., et al., Augmentation of Spinal Arthrodesis With Autologous Bone Marrow in a Rabbit Posterolateral Spine Fusion Model. Spine, 1999 March 1, 24(5 ): 434-8.28 - Deakin, D.E., Bannister, G.C., Graft Incorporation After Acetabular and Femoral Impaction Grafting With Washed Irradiated Allograft and Autologous Marrow. The Journal of Arthroplasty, 2007 January; 22(1): 89-94.29 - Kim, K.J., et al., Effect of Bone Marrow Grafting on the Titanium Porous-Coated Implant in Bilateral Total Knee Arthroplasty. Acta Orthopaedica, 2007 February; 78(1): 116-22.

    A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particularproduct when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons betrained in the use of any particular product before using it in surgery. The information presented in this brochure isintended to demonstrate a Stryker product. Always refer to the package insert, product label and/or user instructionsbefore using any Stryker product. Products may not be available in all markets. Product availability is subject to theregulatory or medical practices that govern individual markets. Please contact your Stryker representative if you havequestions about the availability of Stryker products in your area.

    Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarksor service marks: Imbibe, Stryker, Vitoss. All other trademarks are trademarks of their respective owners or holders.

    Literature Number: 5701-0000 Rev. 00AQ/LW 08/11

    Copyright 2011 StrykerPrinted in USA

    Num

    ber o

    f Bon

    e G

    raft

    Pro

    duct

    s

    Year

    200180160140120100806040200

    1996

    1997

    1998

    1999

    2000

    2001

    2002

    2003

    2004

    2005

    2006

    2007

    EMS Equipment

    Patient Handling Equipment

    Imaging

    Communications

    Endoscopy

    Navigation

    Interventional Spine

    Neuro & ENT

    Surgical Products

    Orthobiologics

    Spine

    Craniomaxillofacial

    Trauma, Extremities, Deformities

    Joint Replacements