1AC-1000L-101 REV D

nvc Anterior Cervical Interbody Fusion System

AC-1000L-101 REV D

2AC-1000L-101 REV D

Device Description:

The nvc is an intervertebral body fusion device used in the cervical spine following discectomy. All devices are manufactured from PEEK Optima® LT1 per ASTM F2026 and include tantalum markers per ASTM F560 for radiographic visualization.The devices have multiple footprints to adapt to the general shape of the vertebral endplates and have a hollow centre to accommodate bone graft.The devices are implanted via an anterior (ACIF) surgical approach. Each footprint is available in multiple heights to accommodate patient variability and there are anti-migration features on the superior and inferior surfaces designed to improve fixation, stability and prevent back out.

Indications for Use:

The nvc is intended for spinal fusion procedures at one level, from C2-T1, in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. One device is to be used per intervertebral space. Patients should receive six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The nvc devices must be used with supplemental fixation and are designed for use with autograft bone to facilitate fusion. The devices are to be implanted via an anterior approach.

WARNINGS:

• Implants and instruments are provided non-sterile and must be sterilized prior to use. Validated sterilization instructions are noted in this insert. nvc implants should never be reused under any circumstances.• The nvc implants must be implanted by an experienced spinal surgeon who has reviewed and undergone training in the use of the nvc system. Preoperative planning, including knowledge of the surgical technique, proper selection of device size, proper placement of the device is critical for the achievement of successful results. Conditions such as levels of implantation, patient weight, patient activity level and other patient conditions may impact the performance of the system and should be taken into consideration during patient selection.• Patients with previous spinal surgery at the level(s) to be treated may have different clinical outcomes compared to those without a previous surgery.• Care must be taken to protect implant surfaces from being scratched, nicked or damaged during handling and storage of the implant as these could become focal points for failure or breakage of the device.• Due to the presence of implants, interference with CT and/or MR imaging may result. The nvc system has not been evaluated for safety and compatibility in the MR environment. The nvc system has not been tested for heating or migration in the MR environment.• Some degree of corrosion occurs on all metal and alloy devices. Contact of dissimilar metals, however, may accelerate the corrosion process. Components of this system should not be used in conjunction

Part No. Description

AC-005-S 12mm x 14mm x 5mm x 0°

AC-006-S 12mm x 14mm x 6mm x 0°

AC-007-S 12mm x 14mm x 7mm x 0°

AC-008-S 12mm x 14mm x 8mm x 0°

AC-009-S 12mm x 14mm x 9mm x 0°

AC-010-S 12mm x 14mm x 10mm x 0°

AC-011-S 12mm x 14mm x 11mm x 0°

AC-012-S 12mm x 14mm x 12mm x 0°

Part No. Description

AC-605-S 12mm x 14mm x 5mm x 6°

AC-606-S 12mm x 14mm x 6mm x 6°

AC-607-S 12mm x 14mm x 7mm x 6°

AC-608-S 12mm x 14mm x 8mm x 6°

AC-609-S 12mm x 14mm x 9mm x 6°

AC-610-S 12mm x 14mm x 10mm x 6°

AC-611-S 12mm x 14mm x 11mm x 6°

AC-612-S 12mm x 14mm x 12mm x 6°

Part No. Description

AC-005-L 14mm x 16mm x 5mm x 0°

AC-006-L 14mm x 16mm x 6mm x 0°

AC-007-L 14mm x 16mm x 7mm x 0°

AC-008-L 14mm x 16mm x 8mm x 0°

AC-009-L 14mm x 16mm x 9mm x 0°

AC-010-L 14mm x 16mm x 10mm x 0°

AC-011-L 14mm x 16mm x 11mm x 0°

AC-012-L 14mm x 16mm x 12mm x 0°

Part No. Description

AC-605-L 14mm x 16mm x 5mm x 6°

AC-606-L 14mm x 16mm x 6mm x 6°

AC-607-L 14mm x 16mm x 7mm x 6°

AC-608-L 14mm x 16mm x 8mm x 6°

AC-609-L 14mm x 16mm x 9mm x 6°

AC-610-L 14mm x 16mm x 10mm x 6°

AC-611-L 14mm x 16mm x 11mm x 6°

AC-612-L 14mm x 16mm x 12mm x 6°

with components of any other manufacturer’s spinal system.

CONTRAINDICATIONS:

Contraindications include, but are not limited to:1. Suspected or documented material allergy or intolerance.2. Patients with infection, inflammation, fever, leukocytosis, obesity, pregnancy, mental illness and other medical conditions which would prohibit beneficial surgical outcomes.3. Grossly distorted anatomy caused by congenital abnormalities.4. Rapid joint disease, bone absorption, osteopenia. Osteoporosis is a relative contraindication since this condition may limit the degree of obtainable correction, stabilization, and/or the amount of mechanical fixation.5. Any patient not described in the indications.6. Any patient unwilling to follow postoperative instructions.7. Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance.8. Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality.9. Any other condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumors, fracture local to the operating site, elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked shift in the WBC differential count.10. Any case where the implant components selected for use would be too large or too small to achieve a successful result.11. Prior fusion at the level(s) to be treated.

Potential Adverse Effects:

Possible adverse events or complications include, but are not limited to:1. Implant migration and/or subsidence2. Breakage of implant3. Foreign body (allergic) reaction to the implants4. Post-operative change in spinal curvature, loss of correction, height, and/or reduction5. Infection6. Loss of neurological function including paralysis (partial or complete), radiculopathy, and/or the development or continuation of pain, numbness, spasms, or sensory loss7. Non-union (pseudoarthrosis), delayed union, mal-union8. Inability to perform the activities of daily living9. Fracture, micro-fracture, resorption, damage or penetration of any spinal bone10. Loss or increase in spinal mobility or function11. Pain, discomfort, or abnormal sensations due to the presence of the device.12. Hemorrhage of blood vessels and/or hematomas13. Herniated nucleus pulposus, disc disruption or degeneration at, above or below the level of surgery14. Post-operative change in spinal curvature, loss of correction, height and/or reduction15. Death.

Available nvc Sizes

3AC-1000L-101 REV D

Implant

Rasp

Case Trial

Inserter

Tamp

Inserter Disassembly: A. Unscrew strike plate (6) from handle (5)B. Slide handle (5) off of inserter tube (4)C. Pull inserter tube (4) off of inserter core (3)D. Push inserter core (3) towards knob on threaded rod (1)E. Rotate core (3) counterclockwise until keys align with open-ings in the base of the outer shaft (2)F. Remove core (3) from outer shaft (2)G. Slide threaded rod (1) out of outer shaft (2)

Inserter Assembly:A. Slide threaded rod (1) into outer shaft (2)B. Slide inserter core (3) into outer shaft (2), twist clockwise and pull slightly until keys sit in notchesC. Slide inserter tube (4) onto core (3)D. Slide tube (4) into handle (5), align keys on outside of tube into slots in handleE. Thread strike plate (6) into handle (5)

KEYS

3

2

1

4

5

6

KEYS

NOTCHES

4AC-1000L-101 REV D

1. Preoperative Planning:The size of implant to be used for the case should be determined prior to beginning the surgery. To maximize stability, the largest implant that can be safely inserted without neural element disruption should be chosen. All parts must be cleaned and sterilized before use.

2. Patient Positioning and Disc Access:Position the patient in a supine position for access to the cervical spine from a standard anterior approach. The intervertebral disc should be excised using standard technique.

Surgical Technique Steps:

5AC-1000L-101 REV D

3. Endplate Preparation:Remove the superficial cartilaginous layers of the endplates to expose bleeding bone.

4. Selection of Implant:The selection of the implant depends on the height, width, and depth of the intervertebral disc space. Select the trial height associated with the preoperative planning. If necessary, controlled and light hammering with a mallet can be used to advance the trial and confirm the height. Final implant height confirmation must be completed under fluoroscopy.

6AC-1000L-101 REV D

Pack autograft bone inside the graft area.

5.Insert Implant:Select the implant that corresponds

to the footprint, shape, and height determined using the trial in step 4.

Engage the threaded insert of the implant with the threaded post on

the inserter. Lateral grooves on the implant will align with tabs on the

inserter for additional stability.

7AC-1000L-101 REV D

The inserter is removed by unthreading from the implant using the turn knob.

The implant has radiographic markers to assess the implant position.

Carefully insert the implant into the distracted segment, ensuring that the orientation is correct. If necessary, controlled and light hammering with a mallet can be used to advance the implant into the intervertebral disc space.

6.Supplemental FixationSupplemental fixation must be used with the nvc implant. Failure to provide supplemental fixation may result in loosening, displacement, or expulsion of the implant.

The tamp instrument may be used to assist with additional

positioning, if necessary.

7. RemovalRemoval of the implant is performed by re-engaging the threaded inserter and carefully extracting the implant.