AVS ASL PEEK SPACER SYSTEM

K061836 · Stryker Spine · MQP · Aug 3, 2006 · Orthopedic

Device Facts

• Record ID: K061836
• Device Name: AVS ASL PEEK SPACER SYSTEM
• Applicant: Stryker Spine
• Product Code: MQP · Orthopedic
• Decision Date: Aug 3, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker Spine AVS™ ASL PEEK Spacer is a vertebral body replacement indicated for use in the thoraco-lumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised during partial and total vertebrectomy procedures due to tumor or trauma, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. It is recommended to pack bone graft material inside the implant. The Stryker Spine AVS™ ASL PEEK Spacer is intended for use with supplemental fixation. The supplemental fixation systems that may be used with the Stryker Spine AVS™ ASL PEEK Spacer include, but are not limited to, Stryker Spine plate or rod systems (XIA, Spiral Radius 90D, and Trio).

Device Story

Vertebral body replacement implant; PEEK material; used in thoraco-lumbar spine (T1-L5) to replace collapsed/unstable vertebrae post-vertebrectomy; restores spinal height; facilitates anterior decompression of neural tissues; requires supplemental fixation (e.g., Stryker plate/rod systems); bone graft material packed inside implant; surgical use by physicians.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

PEEK (Polyetheretherketone) spacer; vertebral body replacement; 12mm x 14mm footprint; heights 9mm-20mm; 0 and 4 degree angles; mechanical implant; non-active; no software.

Indications for Use

Indicated for patients requiring vertebral body replacement in the thoraco-lumbar spine (T1-L5) following partial or total vertebrectomy due to tumor or trauma; intended to restore height and achieve anterior decompression of spinal cord and neural tissues; requires use with supplemental fixation; bone graft material recommended.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• AVSTM ASL PEEK Spacer (K051205)

Reference Devices

• XIA (Stryker Spine)
• Spiral Radius 90D (Stryker Spine)
• Trio (Stryker Spine)

Submission Summary (Full Text)

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# Special 510(k) Premarket Noti

AUG 0 3 2006

#### Special 510(k) Summary of Safety and Effectiveness: Line Extension to the AVSTM ASL PEEK Spacer System

AVSTM ASL PEEK Spacer System Proprietary Name: Common Name: Vertebral Body Replacement Proposed Regulatory Class: Class II Spinal Vertebral Body Replacement Device 21 CFR 888.3060 Device Product Code: MOP For Information contact: Ms. Simona Voic Regulatory Affairs Project Manager 2 Pearl Court Allendale, NJ 07401 Telephone: [phone] Fax: [phone] Email: Simona. [e-mail] Date Summary Prepared: June 28, 2006 Stryker Spine AVSTM ASL PEEK Spacer Predicate Device: (K051205)

#### Description of Device Modification:

This Special 510(k) submission is intended to introduce sixteen new sizes of the AVSTM AS PEEK Spacer to the Stryker Spine AVSTM ASL PEEK Spacer, determined Substantially Equivalent via 510(k) #K051205. The new sizes all have the Anterior/Posterior (AP) and Medial/Lateral (ML) footprint of 12mm x 14mm, and range in height from 9mm to 20mm. Each new size is available in a 0 degree and 4 degree angle.

#### Intended Use:

The Stryker Spine AVS™ ASL PEEK Spacer is a vertebral body replacement indicated for use in the thoraco-lumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised during partial and total vertebrectomy procedures due to tumor or trauma, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.

It is recommended to pack bone graft material inside the implant.

The Stryker Spine AVS™ ASL PEEK Spacer is intended for use with supplemental fixation. The supplemental fixation systems that may be used with the Stryker Spine

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AVS™ ASL PEEK Spacer include, but are not limited to, Stryker Spine plate or rod systems (XIA, Spiral Radius 90D, and Trio).

### Summary of the Technological Characteristics:

Documentation is provided which demonstrates the additional sizes of the Stryker Spine AVS™ ASL PEEK Spacer to be substantially equivalent to its predicate device in terms of its material, design, and indications for use. Testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 was completed for the Stryker Spinal AVSTM ASL PEEK Spacer.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle-like symbol composed of three curved lines, representing the department's mission to protect the health of all Americans and provide essential human services. The department's name is inscribed in a circular pattern around the symbol, reading "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 0 3 2006

Stryker Spine % Ms. Simona Voic Regulatory Affairs Project Manager 2 Pearl Court Allendale, New Jersey 07401

Re: K061836

Trade/Device Name: AVS™ ASL PEEK Spacer System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MOP Dated: June 27, 2006 Received: July 11, 2006

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 vour 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 svstems (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. 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 Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.

Herbert Weiner us

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):

Device Name: Line Extension to the AVS™ ASL PEEK Spacer System

Indications for Use:

The Stryker Spine AVS™ ASL PEEK Spacer is a vertebral body replacement indicated for use in the thoraco-lumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body resected or excised during partial and total vertebrectomy procedures due to tumor or trauma, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.

It is recommended to pack bone graft material inside the implant.

The Stryker Spine AVS™ ASL PEEK Spacer is intended for use with supplemental fixation. The supplemental fixation systems that may be used with the Stryker Spine AVS™ ASL PEEK Spacer include, but are not limited to, Stryker Spine plate or rod systems (XIA, Spiral Radius 90D, and Trio).

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hubert Leuner

(Division Division of General, Restorative, and Neurological Devices

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510(K) Number k061836