AVS PL PEEK SPACERS, MODELS 48351XXX AND 48353XXX

K073470 · Stryker Spine · MAX · Mar 6, 2008 · Orthopedic

Device Facts

• Record ID: K073470
• Device Name: AVS PL PEEK SPACERS, MODELS 48351XXX AND 48353XXX
• Applicant: Stryker Spine
• Product Code: MAX · Orthopedic
• Decision Date: Mar 6, 2008
• Decision: SESE
• Submission Type: Traditional
• 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 Spacers are rectangular, hollow-frame intervertebral body fusion implants with lateral fenestrations; designed for posterior approach spinal fusion. Implants feature Tantalum marker pins for radiographic visualization; available in various heights (6-13mm), lengths (30-33mm), and wedge angles (0° or 4°). Used by surgeons in clinical settings to facilitate fusion in patients with degenerative disc disease. Device acts as a structural spacer to maintain disc space height while bone graft promotes fusion; requires concurrent use of cleared supplemental posterior pedicle screw and rod fixation systems. Benefits include stabilization of spinal segments and support for arthrodesis.

Clinical Evidence

Bench testing only. No clinical data provided. Performance was evaluated in compliance with the FDA's 'Class II Special Controls Guidance Document: Intervertebral Body Fusion Device' to demonstrate substantial equivalence.

Technological Characteristics

Materials: PEEK (Polyetheretherketone) and Tantalum (marker pins). Form factor: Rectangular, hollow-frame with lateral fenestrations. Dimensions: 6-13mm height, 30-33mm length, 11mm width; 0° and 4° wedge options. Principle: Intervertebral body fusion spacer. 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 Ray Threaded Fusion Cage (TFC) (P950019)
• DePuy AcroMed, Inc. Lumbar I/F Cage with VSP Spine System (P960025)
• Synthes Spine SynFix - LR (K072253)

Submission Summary (Full Text)

{0}------------------------------------------------

K073470

MAR - 6 2008

## Stryker Spine AVS PL PEEK Spacers

## Traditional 510(k) Premarket Notification

## 510(k) Summary: AVS PL PEEK Spacers

| Submitter: | Stryker Spine<br>2 Pearl Court<br>Allendale, New Jersey 07401 |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Ms. Simona Voic<br>Regulatory Affairs Project Manager<br>Phone: [phone]<br>FAX: [phone]<br>Email: [e-mail] |
| Date Prepared | March 3, 2008 |
| Trade Name | Stryker Spine AVS PL 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 Ray Threaded Fusion Cage (TFC)TM with<br>instrumentation: P950019;<br>DePuy AcroMed, Inc. Lumbar I/F Cage® with VSP Spine<br>System: P960025.<br>Synthes Spine SynFixTM - LR: K072253. |
| Device Description | The AVS PL Peek Spacers are intervertebral body fusion devices<br>intended for use as an aid in spinal fixation. The AVS PL PEEK<br>Spacers are rectangular shaped, hollow frame implants with<br>lateral fenestrations. The spacers incorporate two (2) Tantalum<br>marker pins to aid in radiographic visualization.<br>The AVS PL PEEK Spacers are available in a variety of sizes,<br>from 6 mm to 13 mm in height, two lengths: 30 mm and 33 mm<br>and one width: 11 mm. There are also 0° and 4° wedge shaped<br>options that allow the surgeon to best choose the size suited to<br>the patient's anatomy and pathology. |
| Intended Use | The Stryker Spine AVS PL 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 S1.<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 PL PEEK Spacers are to be implanted via posterior<br>approach.<br>The AVS PL 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 PL PEEK Spacers<br>and demonstrated substantial equivalent performance<br>characteristics to the identified predicate device systems. |

・

. .

{1}------------------------------------------------

{2}------------------------------------------------

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 stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Stryker Spine % Ms. Simona Voic 2 Pearl Court Allendale, NJ 07401

MAR - 6 2008

Re: K073470

Trade/Device Name: Stryker Spine AVS PL PEEK Spacers Regulation Number: 21 CFR 888.3080 Regulation Names: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: December 7, 2007 Received: December 10, 2007

Dear Ms. Voic:

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.

{3}------------------------------------------------

Page 2 - Ms. Simona Voic

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 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 Miller

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

Enclosure

{4}------------------------------------------------

Stryker Spine AVS PL PEEK Spacers

## Indications for Use

510(k) Number (if known): K ( 73470 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).

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)

Neil R R Qde for nxm

Division of General, Restorative and Neurological Devices

Page 1 of 1

510(k) Number K073470