AVS TL PEEK SPACERS

K083661 · Stryker Corp. · MAX · Feb 27, 2009 · Orthopedic

Device Facts

• Record ID: K083661
• Device Name: AVS TL PEEK SPACERS
• Applicant: Stryker Corp.
• Product Code: MAX · Orthopedic
• Decision Date: Feb 27, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker Spine AVS® TL 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® TL PEEK Spacers are to be implanted via posterior approach. The AVS® TL 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® TL PEEK Spacers are banana-shaped, hollow-frame intervertebral body fusion implants; feature lateral fenestrations and three Tantalum marker pins for radiographic visualization. Available in various heights (7-18mm), two lengths (25mm, 30mm), one width (9mm), and two lordotic options (0° parallel, 4° wedge). Implanted via posterior approach by surgeons to facilitate spinal fusion in the lumbosacral spine. Used in conjunction with supplemental posterior pedicle screw and rod fixation systems. Device provides structural support to the intervertebral space while autogenous bone graft promotes fusion; helps restore disc height and stabilize the spinal segment in patients with DDD.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Material: PEEK (Polyetheretherketone) with Tantalum marker pins. Form factor: Banana-shaped hollow frame with lateral fenestrations. Dimensions: 7-18mm height, 25/30mm length, 9mm width. Options: 0° parallel or 4° wedge. Energy source: None (mechanical implant). 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. 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

• Stryker Spine AVS® PL PEEK Spacers (K073470)
• DePuy AcroMed, Inc. Lumbar I/F Cage® with VSP Spine System (P960025)

Submission Summary (Full Text)

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K058366|

Stryker Spine AVS® TL PEEK Spacers

Traditional 510(k) Premarket Notification

# FEB ஓ 7 2009

510(k) Summary: AVS® TL PEEK Spacers

| Submitter: | Stryker Spine<br>2 Pearl Court<br>Allendale, New Jersey 07401 |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Ms. Kimberly Lane<br>Regulatory Affairs Specialist<br>Phone: [phone]<br>FAX: [phone]<br>Email: [e-mail] |
| Date Prepared | December 9, 2008 |
| Trade Name | Stryker Spine AVS® TL 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>DePuy AcroMed, Inc. Lumbar I/F Cage® with VSP Spine<br>System: P960025. |
| Device Description | The AVS® TL Peek Spacers are intervertebral body fusion<br>devices intended for use as an aid in spinal fixation. The Stryker<br>Spine AVS® TL PEEK Spacer is a "banana" shaped, hollow<br>frame implant with lateral fenestrations. The spacers incorporate<br>three (3) Tantalum marker pins to aid in radiographic<br>visualization.<br>The Stryker Spine AVS® TL PEEK Spacer is available in a<br>variety of sizes, from 7 mm to 18mm in height, two (2) lengths:<br>25 mm and 30 mm and one (1) width: 9 mm. There are also 0°<br>parallel and 4° wedge shaped options, which allows the surgeon<br>to best choose the size suited to the patient's anatomy and<br>pathology. |
| Intended Use | The Stryker Spine AVS® TL PEEK Spacers are intervertebral<br>body fusion devices indicated for use with autogenous bone graft<br>in patients with degenerative disc disease (DDD) at one level or<br>two contiguous levels from L2 to \$1.<br>DDD is defined as back pain of discogenic origin with<br>degeneration of the disc confirmed by history and radiographic<br>studies. The DDD patients may also have up to Grade I<br>spondylolisthesis at the involved level(s). These patients should<br>be skeletally mature and have six months of nonoperative<br>therapy.<br>The AVS® TL PEEK Spacers are to be implanted via posterior<br>approach.<br>The AVS® TL PEEK Spacers are intended to be used with<br>supplemental spinal fixation systems that have been cleared for<br>use in the lumbosacral spine (i.e., posterior pedicle screw and<br>rod systems). |
| Summary of the<br>Technological<br>Characteristics | Testing in compliance with FDA's June 12, 2007 "Class II<br>Special Controls Guidance Document: Intervertebral Body<br>Fusion Device" was performed for the AVS® TL PEEK Spacers<br>and demonstrated substantial equivalent performance<br>characteristics to the identified predicate device systems. |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with outstretched wings and three legs.

Public Health Service

FEB 2-7 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K083661

Trade/Device Name: Stryker Spine AVS® TL PEEK Spacers Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: December 9, 2008 Received: December 10, 2008

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 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. Kimberly Lane

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.

R.A. m.d. fo

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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Stryker Spine AVS® TL PEEK Spacers

Traditional 510(k) Premarket Notification

## Indications for Use

510(k) Number (if known): KOS 3461 Device Name: Stryker Spine AVS® TL PEEK Spacers

#### Indications For Use:

The Stryker Spine AVS® TL PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft bone 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® TL Spacers are to be implanted via posterior approach.

The AVS® TL 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) 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)

AND/OR

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(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Numbe