Supporting healthcare professionals

The power of robotics in your skilled handsThe NAVIO Surgical System provides accuracy, flexibility and confidence utilizing real-time imaging (without the need for preoperative CT), hand-held robotics, a portable cart, and multiple partial and total knee implant options in an economically sound1 platform. Supporting healthcare professionals

The need for improvements in healthcare

Patients are demanding improved quality of life

Knee arthroplasty has a highly successful track record as a surgical intervention, yet patient satisfaction ratings indicate 10–30% of patients remain dissatisfied.2–6

Running an effective practice is dependent on reproducible results and improving patient outcomes7

Reduce readmissions and complications7

Readmissions are considered to be a quality indicator in many healthcare systems and in many instances hospitals are financially penalized for avoidable readmissions (e.g. Medicare Hospital Readmission Reduction Program)8

Quality of life

10–30%dissatisfaction

Why NAVIO™?The NAVIO Surgical System is designed to aid surgeons in component positioning, ligament balancing and bone preparation – key factors that can drive implant survivorship.9,10

The NAVIO Surgical System does this without requiring a CT scan and allows surgeons, staff and patients the experience of a patient-specific plan without the extra steps associated with other image-based robotic-assisted technologies that can increase cost or delay surgery1.

Real-time imaging

Handheld robotics

Portable cart

Multiple implant options

Economically sound1

Accuracy Flexibility Confidence

Image-free registration

• A 3D model of the patient's cartilage and bone is captured through direct surface mapping, eliminating the need for a CT scan

Patient specific planning

• 3D implant planning provides confidence in sizing, placement, and resection depth

• For total and unicompartmental knees, patient-specific planning allows the surgeon to place implant components virtually and predict postoperative joint laxity at the time of surgery without being locked into a plan before verifying the severity of the disease

• Soft tissue balancing can be viewed throughout the full range of motion

Robotics-assisted bone preparation

• Patented NAVIO™ handheld burring technology removes only the bone determined by the surgeon plan

• Bone removal is seen on the NAVIO screen in real-time allowing the surgeon to continually assess patient anatomy against the plan

Confirmation

• For UKA and TKA, confirm postoperative joint laxity versus planned

• Varus/valgus balance is assessed to confirm the achieved long-leg alignment

• Flexibility to perform and evaluate ligament releases

Next generation of roboticsHow it works

Real-time imagingEliminates time and costs associated with preoperative CT imaging

• Simplifies the surgical process

• Reduces radiation exposure for patients

− The mean dose associated with the preoperative CT for robotic-assisted knee arthroplasty is equivalent to 48 chest radiographs11

− Furthermore, one or more additional CT scans were obtained in 25% of patients, according to one study of 211 patients11

• Enables office staff to focus on patient care by eliminating the need to spend time managing payer approvals for preoperative imaging

• Saves the healthcare system incremental cost of CT

Diagnostics Recovery

Image-based robotics-assisted workflow

NAVIO™ image-free robotics-assisted workflow

Accuracy Flexibility Confidence

Diagnostics Intraop planning and surgery

Intraop planning and surgery

RecoveryCT Preop planning

2

4

56

3

Accuracy

Flexibility

Flexibility

Confidence

1

• Easily move the cart from OR to OR or facility to facility, providing flexibility and efficiencies

• Features simple calibration and a footprint designed for use in the surgery center or hospital

Portable cart with a small footprint

• Places robotics-assisted surgery in your hands

• Allows flexibility of multiple bone removal options [Bur | Saw | Combo]

• Provides accurate burring for bulk bone removal or fine tune adjustments

The NAVIO™ handpiece accurately removes bone identified by the surgeon approved, patient-specific plan12

Provides the confidence of handheld robotics

The NAVIO handpiece offers a unique and flexible approach to knee arthroplasty

Flexibility

1 Handpiece

2 Tracking array

3 Infrared reflective discs

4 High speed internal drill

5 Interchangeable guard

6 Cutting bur

Implant optionsProvides the flexibility of multiple implant options for partial and total knees to accommodate surgeon and patient needs

STRIDE ZUK UNIJOURNEY UNI JOURNEY PFJ JOURNEY II CR GENESIS II PS/CR LEGION PRIMARY BCS/CR

ConfidenceFlexibility

*NAVIO with JOURNEY II XR not available for commercial use until 2018

JOURNEY II XR*JOURNEY II BCS JOURNEY II CR

Supports the JOURNEY™ II Total Knee which is designed for normal function, smoother recovery and improved patient satisfaction

Components made with OXINIUM™ alloy, an advanced material shown to be 4,900 times more resistant to abrasion18, more than twice as hard19, and has a coefficient of friction that is up to half that of CoCr20

Supports STRIDE UNI, designed to be optimized for robotics

Offers a selection of implant options with a strong clinical heritage including ZUK UNI13, GENESIS™ II14 and LEGION™ Primary15–17

Economically sound1

A cost effective1 approach to building a cutting-edge surgical practice, designed to deliver outcomes predictable to the plan

• Distinguishing technology can draw patient interest and grow case volume21–22

• Potential to increase patient volume by offering advanced surgical techniques and increasing access to unicompartmental and patellofemoral procedures

• Episode of care costs are decreased with the elimination of a preoperative CT

Confidence

Smith & Nephew, Inc.

2905 Northwest Blvd., Suite 40 Plymouth, MN 55441 USA

Supporting healthcare professionals for over 150 years

References 1. Sg2 Healthcare Intelligence. Technology Guide: Orthopedic Surgical Robotics. 2014. 2. Pastides P, Nathwani D. The role of newer technologies in knee arthroplasty. Orthopaedics and Trauma (2016). http://dx.doi.org/10.1016/j.mporth.2016.10.003. 3. Banerjee S, Cherian JJ, Elmallah RK, Jauregui JJ, Pierce TP, Mont MA. Robotic-assisted knee arthroplasty. Expert review of medical devices. 2015;12(6):727-735. 4. Urish KL, Conditt M, Roche M, Rubash HE. Robotic Total Knee Arthroplasty: Surgical Assistant for a Customized Normal Kinematic Knee. Orthopedics. Sep 01 2016;39(5):e822-827. 5. Nodzo SR, Carroll KM, Mayman DJ. Disposable Navigation for Total Knee Arthroplasty. Am J Orthop (Belle Mead NJ). May-Jun 2016;45(4):240-245. 6. Abdel MP, Oussedik S, Parratte S, Lustig S, Haddad FS. Coronal alignment in total knee replacement: historical review, contemporary analysis, and future direction. The bone & joint journal. Jul 2014;96-b(7):857-862. 7. Centers for Medicare & Medicare Services. <https://www.cms.gov/medicare/medicare-fee-for-service-payment/acuteinpatientpps/readmissions-reduction-program.html. Accessed 06/01/17>. 8. Readmissions Reduction Program (HRRP). CMS.gov. Page last Modified: 04/18/2016 5:08 PM. 9. Sharkey, P., et al. “Why Are Total Knee Arthroplasties Failing Today?” Clinical Orthopaedics and Related Research. 2002 Nov;404:7-13. 10. Siddique, N., Ahmad, Z. “Revision of Unicondylar to Total Knee Arthroplasty: A Systematic Review” The Open Orthopae-dics Journal 2012;6; (Suppl 2: M2) 268-275. 11. Ponzio DY, Lonner JH, Preoperative Mapping in Unicompartmental Knee Arthroplasty Using Computed Tomography Scans Is Associated with Radiation Exposure a..., J Arthroplasty (2014), http://dx.doi.org/10.1016/j.arth.2014.10.039. 12. Lonner J., Smith J., et al. High Degree of Accuracy of a Novel Image-free Handheld Robot for Unicondylar Knee Arthroplasty in a Cadaveric Study. Clin Orthop Relat Res 2014 Jul 8. Epub 2014 Jul 8. 13. Australian Orthopaedic Association National Joint Replacement Registry. Annual Report. Adelaide:AOA; 2015. 14. McCalden RW, Hart GP, MacDonald SJ, Naudie DD, Howard JH, Bourne RB, Clinical Results and Survivorship of the Genesis II Total Knee Arthroplasty at a Minimum of 15 Years, The Journal of Arthroplasty (2017), doi: 10.1016/j.arth.2017.02.006. 15. LEGION™ Primary Knee System: A Prospective, Multi-Center, Non-Randomized, Safety and Efficacy Clinical Study of the LEGION Primary Knee System for Primary Total Knee Replacement in Subjects with Degenerative Knee Disease. 10-K300-95301, 29 April 2014. Version 1.0. 16. 2016 UK National Joint Registry. Figure 3.16 (a). Page 100. 17. Smith & Nephew Literature: 02961 V2 LEGION Clinical Heritage Brochure 03/17. 18. Hunter, G., and Long, M. Abrasive Wear of Oxidized Zr-2.5Nb, CoCrMo, and Ti-6Al-4V Against Bone Cement. 6th World Biomaterials Cong. Trans., Society for Biomaterials, Minneapolis, MN, 2000, p. 835. 19. Long, M., Riester, L., and Hunter, G. Nano-Hardness Measurements of Oxidized Zr-2.5Nb and Various Orthopaedic Materials. Trans. Soc. Biomaterials, 21, 1998, p. 528. 20. Poggie RA, Wert J, Mishra A, et al (1992). Friction and wear characterization of UHMWPE in reciprocating sliding contact with Co-Cr, Ti-6Al-4V, and zirconia implant bearing surfaces. Wear and Friction of Elastomers, Denton R and Keshavan MK, Eds., West Conshohocken, PA: ASTM International. 21. Smith & Nephew Literature: 06961 V1 NAVIO Surgical System Case Study – Shasta Regional Medical Center 08/16. 22. Smith & Nephew Literature: 07762 V1 NAVIO Surgical System Case Study – St. Mary’s Medical Center 03/17.

For detailed device information, including indications for use, contraindications, effects, precautions and warnings, please consult the product’s Instructions for Use (IFU) prior to use. Promotion and advertising of Smith & Nephew products is to be on-label and consistent with authorized indications and intended uses as stated in the product’s IFU. The information presented is solely for informational and educational purposes. Smith & Nephew does not provide medical advice. This information is not intended to serve as medical advice. The information contained herein may not be appropriate for all jurisdictions.

To learn more about NAVIO™ robotics-assisted orthopaedic surgery or to set up a demonstration, visit www.NAVIOrobotics.com

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