STRYKER SPINE AVS PL PEEK SPACER

K050624 · Stryker Spine · MQP · Apr 11, 2005 · Orthopedic

Device Facts

• Record ID: K050624
• Device Name: STRYKER SPINE AVS PL PEEK SPACER
• Applicant: Stryker Spine
• Product Code: MQP · Orthopedic
• Decision Date: Apr 11, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker Spine AVS™ PL 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 procedure 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™ PL PEEK Spacer is intended for use with supplemental fixation. The supplemental fixation systems that may be used with the Stryker Spine AVS™ PL 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™ PL PEEK Spacer is a vertebral body replacement implant designed for thoraco-lumbar (T1-L5) spinal reconstruction. The device is surgically implanted by a surgeon to replace vertebral bodies compromised by tumor or trauma. It functions as a structural spacer to restore vertebral height and facilitate anterior decompression of neural tissues. The implant is designed to be packed with bone graft material to promote fusion. It is not a standalone device and must be used in conjunction with supplemental fixation systems, such as Stryker Spine plate or rod systems (e.g., XIA, Spiral Radius 90D, Trio). The device provides mechanical support to the spinal column, potentially benefiting patients by stabilizing the spine and relieving neurological compression.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing performed in accordance with the FDA's Guidance for Spinal System 510(k)s (May 3, 2004).

Technological Characteristics

The device is a vertebral body replacement spacer constructed from PEEK (Polyetheretherketone). It is designed for use in the thoraco-lumbar spine. The system is intended for use with supplemental fixation (plate or rod systems). No specific energy source or software is utilized; the device is a passive mechanical implant.

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 of spinal cord/neural tissues. Requires 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 Vertebral Spacer (K040731)
• Stryker Spine AVS™ TL PEEK Spacer (K042571)
• Medtronic Sofamor Danek VERTE-STACK™ Spinal System (K031780)
• DePuy Surgical Titanium Mesh™ (K003043)
• Surgical Dynamics Mesh Cage System (K003709)

Submission Summary (Full Text)

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510(k) Premarket Notification

## APR J 1 2005

## 510(k) Summary of Safety and Effectiveness:
Stryker Spine AVS™ PL PEEK Spacer

| 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 9, 2005 |
| Trade Name | Stryker Spine AVSTM PL PEEK Spacer |
| Classification Name<br>and Number | Spinal Vertebral Body Replacement Device,<br>21 CFR 888.3060 |
| Product Code | MQP |
| Purpose of the<br>premarket notification | The purpose of this premarket notification is to add indications and<br>new implant sizes to the previously cleared Stryker Spine Vertebral<br>Spacer. |
| Predicate Devices | 1) Stryker Spine Vertebral Spacer (K040731)<br>2) Stryker Spine AVSTM TL PEEK Spacer (K042571)<br>3) Medtronic Sofamor Danek VERTE-STACKTM Spinal<br>System (K031780)<br>4) DePuy Surgical Titanium MeshTM (K003043)<br>5) Surgical Dynamics Mesh Cage System (K003709) |
| Intended Use | The Stryker Spine AVSTM PL PEEK Spacer is a vertebral body<br>replacement indicated for use in the thoraco-lumbar spine (T1-L5) to<br>replace a collapsed, damaged, or unstable vertebral body resected or<br>excised during partial and total vertebrectomy procedure due to<br>tumor or trauma, to achieve anterior decompression of the spinal<br>cord and neural tissues, and to restore the height of a collapsed |
| Summary of the<br>Technological<br>Characteristics | vertebral body.<br>It is recommended to pack bone graft material inside the implant.<br>The Stryker Spine AVS™ PL PEEK Spacer is intended for use with<br>supplemental fixation. The supplemental fixation systems that may<br>be used with the Stryker Spine AVS™ PL PEEK Spacer include, but<br>are not limited to, Stryker Spine plate or rod systems (XIA, Spiral<br>Radius 90D, and Trio). |
| | Documentation is provided which demonstrates the Stryker Spine<br>AVS™ PL PEEK Spacer to be substantially equivalent to its<br>predicate devices in terms of its material, sizes, and indications for<br>use. Testing to demonstrate compliance with FDA's Guidance for<br>Spinal System 510(k)'s May 3, 2004 was completed for the Stryker<br>Spinal AVS™ PL PEEK Spacer. |

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APR 1 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K050624

K050624
Trade/Device Name: Stryker Spine AVS™ PL PEEK Spacer System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: March 9, 2005 Received: March 11, 2005

Dear Ms. Voic:

We have reviewed your Section 510(k) premarket notification of intent to market the device indication We have reviewed your Section > ro(x) premainer is substantially equivalent (for the indications
referenced above and have determined the device is substant in interested in for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for tuse stated in the encrosure) to regars names date of the Medical Device American so to commerce prior to May 26, 1776, the characterial and of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the Analystics (RMA) devices that have been reciassified in docordance what a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval app and Cosmetic Act (Act) that do not roquire approvial controls provisions of the Act. The
You may, therefore, market the device, subject to the general magatestion, listing You may, merelove, market the dovices, belyer to the one of the sensual registration, listing of general controls provisions of the free meralies sequilibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classifica (secrated in the Existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional connounce "Entroling cargers" on addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. be found in the Ood of reasons concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA's issualice of a subscance complies with other requirements of the Act
that FDA has made a determination that your device complies . You must that FDA has made a decertimation that your assess of a secret by other Federal agencies and ligit or any Federal statures and regularions daministered of not limited to: registration and listing (21 let comply with an the Act 3 requirements) news 801); good manufacturing practice requirements as setsen CFR Part 807); labeling (21 CFR Part 001); good frankat 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 1050 forth in the quality systems (QD) regalates (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1

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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,

Stypt Plurle

Miriam Provost, Ph.D. 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):_

Device Name:_Stryker_Spine AVS™ PL_PEEK_Spacer

Indications For Use:

The Stryker Spine AVS™ PL PEEK Spacer is a vertebral body replacement indicated The Otlyker Spine / N C / 1-L5) to replace a collapsed, damaged, or for use in the thoraco lumbul opino ( + = => < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < > > > > > > unstable vertebrar body rooooted of the nechieve anterior decompression of the spinal procedures due to tradinal to tradinal to theight of a collapsed vertebral body. oord and nodial to pack bone graft material inside the implant.

The Stryker Spine AVS™ PL PEEK Spacer is intended for use with supplemental fixation. The supplemental fixation systems that may be used with the Stryker Spine fixation: The supplicinal hiation of Jimited 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)

Stent Clarke

on-() Division of General, Restorative, and Neurological Devices

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**510(k) Number** K050624