SYNEX II

K061891 · Synthes Spine Co.Lp · MQP · Aug 18, 2006 · Orthopedic

Device Facts

• Record ID: K061891
• Device Name: SYNEX II
• Applicant: Synthes Spine Co.Lp
• Product Code: MQP · Orthopedic
• Decision Date: Aug 18, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synex™ II implant is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor or trauma (i.e., fracture). The Synex II device is intended to be used with Synthes supplemental internal fixation systems, e.g., TSLP, Pangea and USS. The Synex II device is designed to provide anterior spinal column support, even in the absence of fusion, for a prolonged period.

Device Story

Synex II is a height-expanding vertebral body replacement device; consists of hollow central body, two telescoping end pieces, locking ring. Walls feature holes for grafting material to facilitate fusion. Endplates available in three sizes; feature pyramidal teeth and spikes for vertebral gripping. Used in thoracolumbar spine (T1-L5) to replace collapsed/unstable vertebral bodies caused by tumor or trauma. Requires use with supplemental internal fixation systems (e.g., TSLP, Pangea, USS). Provides anterior spinal column support; maintains stability even without fusion for prolonged periods.

Clinical Evidence

Bench testing only. Mechanical testing performed in accordance with the 'Guidance for Spinal System 510(k)s' (May 3, 2004).

Technological Characteristics

Materials: Titanium alloy, Ti6Al7Nb (ASTM F 1295). Design: Height-expanding, telescoping cylindrical body with locking ring and endplates. Connectivity: None. Energy source: None. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring vertebral body replacement in the thoracolumbar spine (T1-L5) due to tumor or trauma (fracture). Must be used with supplemental internal fixation systems.

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

• Synex™ Spacer (K003836)

Reference Devices

• DePuy Stackable Cage System (K001340)

Submission Summary (Full Text)

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K061891 pg 1 of 2

#### 5.0 510(K) Summary

.

# AUG 1 8 2006

·

| Name of Firm | Synthes Spine Co. L.P.<br>1302 Wrights Lane East<br>West Chester, PA 19380 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact | Bonnie J. Smith |
| Device Trade Name | Synex ^™ II |
| Common/Classification Name | Spinal intervertebral body fixation device |
| Panel/Product Code and Classification | Panel Code 87<br>Product Code MQP<br>21 CFR 888.3060: Class II |
| Predicate Device | K003836 - Synex ^™ Spacer |
| Device Description | The Synex II Spacer is a height expanding vertebral<br>body replacement device consisting of a hollow central<br>body and two endplates. The cylindrical body is<br>comprised of two telescoping end pieces and a locking<br>ring. The walls of the hollow cylindrical body have a<br>plurality of holes intended for the placement of grafting<br>materials to help achieve a solid fusion. Endplates are<br>available in three footprint sizes. Each endplate is<br>angled, has a plurality of holes and is designed with<br>pyramidal teeth and small spikes to grip the adjacent<br>vertebra. |
| Indications for Use | The Synex II Spacer is a vertebral body replacement<br>device intended for use in the thoracolumbar spine (T1-<br>L5) to replace a collapsed, damaged, or unstable<br>vertebral body due to tumor or trauma (i.e., fracture).<br>The Synex II device is intended to be used with<br>Synthes supplemental internal fixation systems, e.g.,<br>TSLP, Pangea, or USS.<br>The Synex II Spacer is designed to provide anterior<br>spinal column support even in the absence of fusion for<br>a prolonged period of time. |

## CONFIDENTIAL

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K044891 pg 2 of 2

#### 5.0 510(K) Summary (continued)

| Substantial Equivalence | The Synthes Synex II Spacer implants are similar to<br>the components of previously cleared spinal systems,<br>Synthes Synex, K003836, and DePuy Stackable Cage<br>System, K001340. The supplement fixation devices<br>for use with the Synex II are cleared for use in<br>patients with tumor, trauma or fractures. |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | All components of the Synex II Spacer are<br>manufactured from titanium alloy, Ti6A17Nb (ASTM<br>F 1295). |
| Performance Data | Mechanical testing in accordance with the "Guidance<br>for Spinal System 510(k)s", issued May 3, 2004, was<br>presented. |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 1 8 2006

Synthes Spine Co. L.P. % Ms. Bonnie J. Smith Regulatory Affairs Project Manager 1302 Wrights Lane East West Chester, Pennsylvania 19380

Re: K061891

Trade/Device Name: SYNEX™ II Spacer Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Vertebral Body Replacement Device Regulatory Class: Class II Product Code: MQP Dated: June 30, 2006 Received: July 3, 2006

Dear Ms. Smith:

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. Bonnie J. Smith

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 (240) 276- 0120. 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 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 Statement

510(k) Number: K061891

Device Name: SYNEX™ II Spacer

The Synex™ II implant is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor or trauma (i.e., fracture). The Synex II device is intended to be used with Synthes supplemental internal fixation systems, e.g., TSLP, Pangea and USS.

The Synex II device is designed to provide anterior spinal column support, even in the absence of fusion, for a prolonged period.

Prescription Use X (21 CFR 801.109 Subpart D) OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chabara buchens for MXM
Division Sign-Off

Division of General, Restorative, and Neurological Devices

510(k) Number