AVS PL PEEK SPACERS

K093704 · Stryker Corp. · MAX · Dec 23, 2009 · Orthopedic

Device Facts

• Record ID: K093704
• Device Name: AVS PL PEEK SPACERS
• Applicant: Stryker Corp.
• Product Code: MAX · Orthopedic
• Decision Date: Dec 23, 2009
• 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 is a hollow-frame intervertebral body fusion device; constructed from PEEK; features lateral fenestrations and superior/inferior surface serrations. Implanted via posterior approach by surgeons to facilitate fusion in lumbar/lumbosacral spine. Used in conjunction with autogenous bone graft and supplemental posterior pedicle screw/rod fixation systems. Device provides structural support to disc space during fusion process; intended to alleviate back pain associated with disc degeneration.

Clinical Evidence

Bench testing only. Performance evaluated in compliance with FDA's 'Class II Special Controls Guidance Document: Intervertebral Body Fusion Device' (June 12, 2007).

Technological Characteristics

Hollow frame intervertebral body fusion device; material: PEEK; features lateral fenestrations and superior/inferior surface serrations; implanted via posterior approach; requires supplemental posterior pedicle screw and rod fixation.

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. Must be used with autogenous bone graft and supplemental posterior spinal fixation.

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 Spacers (K080758, K082014, K090816)
• DePuy AcroMed, Inc. Lumbar I/F Cage with VSP Spine System (P960025)

Submission Summary (Full Text)

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K093704 Page 1 of 2

**Special 510(k) Premarket Notification**

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

Proprietary Name:

DEC 2 3 2009

AVS® PL PEEK Spacer System

Common Name:

Spinal Fixation Appliances

Proposed Regulatory Class:

Class II

Intervertebral body fusion device 21 CFR 888.3080

Device Product Code:

MAX

Kimberly Lane

For Information contact:

Date Summary Prepared:

Predicate Device

Predicate Device Information

Regulatory Affairs Specialist 2 Pearl Court Allendale, NJ 07401 Telephone: [phone] Fax: [phone] Email: [e-mail]

November 30, 2009

AVS® PL PEEK Spacers and DePuy AcroMed, Inc. Lumbar I/F Cage with VSP Spine System: P960025 (i.e., Brantigan Cage) The subject AVS PL PEEK Spacers and the predicates AVS PL PEEK Spacers and DePuy's Lumbar I/F Cage (i.e., Brantigan Cage) share similar design features:

- · Hollow frame PEEK Implant
- · Lateral fenestrations
- · Serrations on the superior and inferior surfaces
- · Comparable heights, widths, and angles
- · Materials and mechanical testing results are similar between the subject device and the listed predicates.

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K093704 Page Lot

**Special 510(k) Premarket Notification**

Description of Device Modification

Intended Use

Summary of the Technological Characteristics

This Special 510(k) premarket notification is intended to introduce the same design modifications applied to the AVS® PL PEEK Spacers cleared under K080758, K082014 and K090816.

Note that the AVS® PL PEEK Spacers may also be referred to as AVS® Plus or AVS® PL-UniLIF.

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).

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/2/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. Inside the circle is a stylized graphic of an abstract bird-like figure, possibly representing a crane or similar bird in flight.

Public Health Service

DEC 2 3 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Stryker Corp. % Stryker Spine Ms. Kimberly Lane 2 Pearl Court Allendale, New Jersey 07401

Re: K093704

Trade/Device Name: Stryker Spine AVS® PL PEEK Spacers Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: November 30, 2009 Received: December 1, 2009

Dear Ms. Lane:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. Kimberly Lane

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative 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 09 3704

Device Name: Stryker Spine AVS® PL PEEK Spacers

Indications For Use:

The Stryker Spine A VS® 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).

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)

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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093704