AVS PL PEEK SPACERS, MODELS 48351 AND 48353

K080758 · Stryker Corp. · MAX · Mar 27, 2008 · Orthopedic

Device Facts

• Record ID: K080758
• Device Name: AVS PL PEEK SPACERS, MODELS 48351 AND 48353
• Applicant: Stryker Corp.
• Product Code: MAX · Orthopedic
• Decision Date: Mar 27, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker Spine AVS PL PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. The AVS PL PEEK Spacers are to be implanted via posterior approach. The AVS PL PEEK Spacers are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).

Device Story

AVS PL PEEK Spacer System is an intervertebral body fusion device; used for spinal stabilization. Implanted via posterior approach; requires supplemental posterior pedicle screw and rod fixation. Design modifications include tapered nose for insertion; removal of anterior threaded hole; adaptation of posterior threaded hole for instrument compatibility; tapered posterior geometry to match vertebral endplates. Used by surgeons in clinical settings to facilitate fusion in DDD patients. Benefits include structural support for vertebral column during bone healing.

Clinical Evidence

No clinical data. Substantial equivalence based on bench testing in compliance with FDA's June 12, 2007 'Class II Special Controls Guidance Document: Intervertebral Body Fusion Device'.

Technological Characteristics

Material: PEEK. Form factor: Rectangular intervertebral spacer with lateral fenestrations. Energy source: None (mechanical implant). Connectivity: None. Sterilization: Not specified. Software: None.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, including those with up to Grade I spondylolisthesis, who have failed six months of nonoperative therapy.

Regulatory Classification

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• AVS PL PEEK Spacer (K073470)
• DePuy AcroMed, Inc. Lumbar I/F Cage (P960025)

Submission Summary (Full Text)

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## Special 510(k) Summary of Safety and Effectiveness: Modifications to the AVSTM PL PEEK Spacer System

LO80758

MAR 2 7 2008

| Proprietary Name: | AVST™ PL PEEK Spacer System |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Spinal Fixation Appliances |
| Proposed Regulatory Class: | Class II<br>Interevertebral body fusion device<br>21 CFR 888.3080 |
| Device Product Code: | MAX |
| For Information contact: | Vikki M. O'Connor<br>Regulatory Affairs Project Manager<br>2 Pearl Court<br>Allendale, NJ 07401<br>Telephone: [phone]<br>Fax: [phone]<br>Email: Vikki.O'[e-mail] |
| Date Summary Prepared: | March 13, 2008 |
| Predicate Device | AVS PL PEEK Spacer, K073470<br>DePuy AcroMed, Inc. Lumbar I/F Cage® with VSP Spine<br>System: P960025 (i.e., Brantigan Cage) |
| Predicate Device Information | The subject AVS PL PEEK Spacers and the predicates AVS PL<br>PEEK Spacers and DePuy's Lumbar I/F Cage (i.e., Brantigan<br>Cage) share similar design features:<br>• Rectangular angled shape<br>• Lateral fenestrations |

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- · Comparable heights, widths, and angles
- · Materials and mechanical testing results are similar between the subject device and the listed predicates.

Description of Device Modification This Special 510(k) premarket notification is intended to introduce the following design changes to the 0° AVSTM PL PEEK Spacers: The ogival shaped nose of the implant has been changed to a tapered design to facilitate insertion. The threaded hole on the front side of the implant has been omitted as it is not needed to remove the implant and field feedback confirms it would likely not be used. In the smaller heights, the back sided threaded hole has been adapted to remain consistent with the existing instruments (i.e., the two Inserters), and the back side of the spacer has been tapered in the frontal plane to match the geometry of the vertebral endplates and the two flat surfaces have been increased to improve connection with the Inserters. Note that the AVS PL PEEK Spacers are also referred to as AVS Plus.

Intended Use

The Stryker Spine AVS PL PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

The AVS PL PEEK Spacers are to be implanted via posterior approach.

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The AVS PL PEEK Spacers are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).

Summary of the Technological Characteristics

Testing in compliance with FDA's June 12, 2007 "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" was performed for the AVS PL PEEK Spacers and demonstrated substantially equivalent performance characteristics to the identified predicate device systems.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract eagle-like symbol with three tail feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 7 2008

Stryker Corporation % Ms. Vikki M. O'Connor 2 Pearl Court Allendale, NJ 07401

Re: K080758

Trade/Device Name: AVS™ PL PEEK Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: March 17, 2008 Received: March 18, 2008

Dear Ms. O'Connor:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Vikki M. O'Connor

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N Millerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K

Device Name: Stryker Spine AVS PL PEEK Spacers

Indications For Use:

The Stryker Spine AVS PL PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

The AVS PL PEEK Spacers are to be implanted via posterior approach.

The AVS PL PEEK Spacers are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).

X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Onetu
(Division Sign-Off)

eral, Restorative. and Neurological Decices

510(k) Number K080758