STRYKER SPINE AVS ASL PEEK SPACER

K051205 · Stryker Spine · MQP · Nov 4, 2005 · Orthopedic

Device Facts

• Record ID: K051205
• Device Name: STRYKER SPINE AVS ASL PEEK SPACER
• Applicant: Stryker Spine
• Product Code: MQP · Orthopedic
• Decision Date: Nov 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker Spine AVSTM 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

The Stryker Spine AVS ASL PEEK Spacer is a ring-shaped, hollow, load-bearing implant machined from medical-grade PEEK OPTIMA LT1. It features lateral fenestrations and serrated superior/inferior surfaces for anchorage. Tantalum marker pins are embedded for radiographic visualization. Available in parallel (0°) and wedge (4°, 8°) configurations to accommodate anatomical variations. The device is implanted by a surgeon during vertebrectomy procedures to replace collapsed or unstable vertebral bodies. Bone graft material is packed inside the hollow center to promote fusion. The device must be used in conjunction with supplemental spinal fixation systems (e.g., XIA, Spiral Radius 90D, Trio) to provide stability. It benefits patients by restoring spinal column height and decompressing neural tissues.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Material: PEEK OPTIMA LT1; Tantalum marker pins. Design: Ring-shaped, hollow frame with lateral fenestrations and serrated surfaces. Configurations: Parallel (0°) and wedge (4°, 8°) shapes. Sterilization: Not specified. Connectivity: None. Energy source: None.

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. Used to restore vertebral height and achieve anterior decompression. Requires use with supplemental fixation.

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

• Stryker Spine AVSTM PL PEEK Spacer (K050624)
• Stryker Spine AVSTM TL PEEK Spacer (K042571)
• Stryker Spine Vertebral Spacer (K040731)
• Globus Medical, Inc. SustainTM Radiolucent Spacer (K040284)
• Synthes Spine Vertebral Spacer (K011037)
• Rezaian Spinal Fixator (K841189)
• DePuy AcroMedTM Inc. Surgical Titanium MeshTM System (K003043)
• Surgical Dynamics Mesh Cage System (K003709)

Submission Summary (Full Text)

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## NOV - 4 2005

## 510(k) Summary of Safety and Effectiveness:
Stryker Spine AVSTM ASL 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 | October 21, 2005 |
| Trade Name | Stryker Spine AVSTM ASL PEEK Spacers |
| Classification Name<br>and Number | Spinal Vertebral Body Replacement Device,<br>21 CFR 888.3060 |
| Product Code | MQP |
| Predicate Devices | 1) Stryker Spine AVSTM PL PEEK Spacer (K050624)<br>2) Stryker Spine AVSTM TL PEEK Spacer (K042571)<br>3) Stryker Spine Vertebral Spacer (K040731)<br>4) Globus Medical, Inc. SustainTM Radiolucent Spacer (K040284)<br>5) Synthes Spine Vertebral Spacer (K011037)<br>6) Rezaian Spinal Fixator (K841189)<br>7) DePuy AcroMedTM Inc. Surgical Titanium MeshTM System (K003043)<br>8) Surgical Dynamics Mesh Cage System (K003709) |
| Product Description | The Stryker Spine AVSTM ASL PEEK Spacer is a ring shaped, hollow frame implant with lateral fenestrations, machined from medical grade PEEK OPTIMA LT1. The AVSTM ASL PEEK Spacer incorporates Tantalum marker pins to aid in radiographic visualization. The upper and lower aspects of the AVSTM ASL PEEK Spacer are open, and the superior and inferior surfaces have serrations that assist in the anchorage and seating of the device. The AVSTM ASL PEEK Spacer is offered in both parallel (0°) and wedge (4° & 8°) shapes. These shapes are available in a variety of footprint sizes to fit the anatomical needs of a wide variety of patients. |
| Intended Use | The Stryker Spine AVSTM 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.<br>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). |
| Summary of the | Documentation is provided which demonstrates the Stryker |
| Technological | Spine AVS™ ASL PEEK Spacer to be substantially equivalent |
| Characteristics | to its predicate devices 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 AVS™ ASL PEEK Spacer. |

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## KOSIZOS

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the HHS emblem, which consists of a stylized caduceus-like symbol with three abstract human figures. The emblem is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 4 2005

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

Re: K051205

Trade/Device Name: AVS™ ASL PEEK Spacer Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: October 21, 2005 Received: October 24, 2005

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.

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Page 2- 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,

Mark N. Melkerson

Mark N. Melkerson (ما Acting 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): KOS | 7 OS

Device Name: Stryker Spine AVS™ ASL PEEK Spacer

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, 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 rod or rod systems (XIA, Spiral Radius 90D, and Trio).

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 General, Restorative, and Neurological Devices

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**510(k) Number** K051205

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