AVS ANTERIOR LARGE PEEK SPACERS

K090166 · Stryker Corp. · MAX · Apr 22, 2009 · Orthopedic

Device Facts

• Record ID: K090166
• Device Name: AVS ANTERIOR LARGE PEEK SPACERS
• Applicant: Stryker Corp.
• Product Code: MAX · Orthopedic
• Decision Date: Apr 22, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker Spine AVS® AL 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® AL PEEK Spacers are to be implanted via an anterior or anterolateral approach. The AVS® AL 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 AL PEEK Spacers are ring-shaped, hollow-frame intervertebral body fusion implants; machined from PEEK OPTIMA LT1; feature lateral fenestrations and serrated superior/inferior surfaces for anchorage; include three Tantalum marker pins for radiographic visualization. Implanted via anterior or anterolateral approach by surgeons; used with autogenous bone graft and supplemental posterior pedicle screw/rod fixation systems. Device provides structural support to intervertebral space to facilitate fusion; benefits patients by stabilizing spinal segments affected by degenerative disc disease.

Clinical Evidence

Bench testing only. Performance verified through mechanical testing in compliance with FDA's 2007 Special Controls Guidance for Intervertebral Body Fusion Devices.

Technological Characteristics

Materials: PEEK OPTIMA LT1 (ASTM F2026) and Tantalum marker pins (ASTM F560). Design: Ring-shaped, hollow-frame with lateral fenestrations and serrated surfaces. Dimensions: Heights 10-20mm, lengths 22-28mm, widths 28-33mm, lordotic angles 4° and 8°. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

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

• Stryker Spine AVS® PL PEEK Spacers (K073470)
• Pillar XL Peek Spacers (K082235)
• DePuy AcroMed, Inc. Lumbar I/F Cage® (i.e., Brantigan Cage) with VSP Spine System (P960025)

Submission Summary (Full Text)

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| Submitter: | Stryker Spine<br>2 Pearl Court<br>Allendale, New Jersey 07401 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Ms. Vikki M. O'Connor<br>Regulatory Consultant<br>Phone: [phone]<br>FAX: [phone]<br>Email: vikki.o'[e-mail] |
| Date Prepared | January 12, 2009 |
| Trade Name | Stryker Spine AVS® AL PEEK Spacers |
| Proposed Class | Class II |
| Classification Name<br>and Number | Intervertebral body fusion device, 21 CFR 888.3080 |
| Product Code | MAX |
| Predicate Devices | Stryker Spine AVS® PL PEEK Spacers: K073470<br>Pillar XL Peek Spacers: K082235<br>DePuy AcroMed, Inc. Lumbar I/F Cage® (i.e., Brantigan Cage)<br>with VSP Spine System: P960025. |
| Device Description | The AVS® AL Peek Spacers are intervertebral body fusion<br>devices intended for use as an aid in spinal fixation. The<br>Stryker Spine AVS® AL PEEK Spacer is a ring shaped, hollow<br>frame implant with lateral fenestrations, machined from medical<br>grade PEEK OPTIMATM LT1 that is radiolucent and<br>incorporates three (3) Tantalum marker pins to aid in<br>radiographic visualization. The upper and lower aspects of the<br>subject device are open, and the superior and inferior surfaces<br>have serrations that assist in the anchorage and seating of the<br>device. |
| | The subject devices are manufactured out of the following |
| | materials: |
| | Spacers: Polyetheretherketone (PEEK) OPTIMA™ LT1<br>(ASTM F2026) |
| | Marker Pins: Tantalum (ASTM F560). |
| | The Stryker Spine AVS™ AL PEEK Spacer family is comprised |
| | of six (6) different heights (10, 12, 14, 16, 18 and 20mm), two |
| | (2) lengths (22 mm and 28 mm), two (2) widths (28 mm and 33 |
| | mm) and lordotic angles of 4° and 8 °, which allows the surgeon |
| | to best choose the size suited to the patient's anatomy and |
| | pathology. (Implant drawings and part numbers can be found in |
| | Section 11 of this application). |
| Intended Use | The Stryker Spine AVS® AL 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® AL PEEK Spacers are to be implanted via an anterior |
| | or anterolateral approach. |
| | |
| | The AVS® AL 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 | Testing in compliance with FDA's June 12, 2007 "Class II |
| Technological | Special Controls Guidance Document: Intervertebral Body |
| Characteristics | Fusion Device" was performed for the AVS® AL PEEK Spacers |
| | and demonstrated substantial equivalent performance |
| | characteristics to the identified predicate device systems. Testing |
| | Reports can be found in Section 18 of this application. |

## 510(k) Summary: AVS® AL PEEK Spacers

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Stryker Spine % Ms. Vikki O'Connor Regulatory Consultant 2 Pearl Court Allendale, New Jersey 07401

APR 2 2 2009

Re: K090166

Trade/Device Name: Stryker Spine AVS® AL PEEK Spacers Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: January 21, 2009 Received: January 22, 2009

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.

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. Vikki O'Connor

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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/cdrh/industry/support/index.html.

Sincerely yours,

for

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 090/66 Device Name: Stryker Spine AVS® AL PEEK Spacers

Indications For Use:

The Stryker Spine AVS® AL 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® AL Peek Spacers are to be implanted via an anterior or anterolateral approach.

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

Prescription Use x (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)

n Sign-Off) Division of General, Restorative, Page 1 of 1 and Neurological Devices

510(k) Number C690164