TITANIUM MESH SYSTEM

K032371 · Encore Medical L.P. · MQP · Feb 12, 2004 · Orthopedic

Device Facts

• Record ID: K032371
• Device Name: TITANIUM MESH SYSTEM
• Applicant: Encore Medical L.P.
• Product Code: MQP · Orthopedic
• Decision Date: Feb 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Titanium Mesh System is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture), to achieve anterior decompression of the spinal cord and other neutral tissues, and to restore the height of a collapsed vertebral body. The Titanium Mesh is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period

Device Story

Vertebral body replacement system; consists of titanium mesh implants in various cross-sectional shapes (round, oval, oblong, kidney) and heights (7mm-130mm); includes trapezoidal options. Implants feature perforated sidewalls for bone fusion and internal longitudinal ribs. System includes corresponding end caps with friction-locking prongs and serrated surfaces for stability. Used in thoracolumbar spine (T1-L5) by surgeons to replace damaged vertebrae, achieve anterior decompression, and restore spinal height. Implant can be trimmed to size at surgical site; interior space filled with bone graft material. Designed to restore biomechanical integrity of spinal column. Used with supplemental internal fixation spinal systems.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and material characteristics.

Technological Characteristics

Manufactured from surgical grade titanium alloy (Ti-6Al-4V) per ASTM F-1108. Features perforated mesh sidewalls, internal longitudinal ribs, and friction-locking end caps with serrated surfaces. Dimensions range from 7mm to 130mm in height. System is intended for use with supplemental internal fixation.

Indications for Use

Indicated for patients with collapsed, damaged, or unstable vertebral bodies in the thoracolumbar spine (T1-L5) resulting from tumor or trauma (fracture).

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

• SynMesh™ Spacer System (K003275)
• Surgical Dynamics™ Mesh Cage System (K003709)
• DePuy AcroMed™ Surgical Titanium Mesh™ System (K003043)

Submission Summary (Full Text)

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142

| k032371 |
|---------|
|---------|

| SUBMITTER: | Encore Orthopedics, Inc.<br>9800 Metric Blvd<br>Austin, TX 78758 |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Kimberly L. Pruitt<br>[phone] |
| PROPRIETARY NAME: | Titanium Mesh |
| COMMON NAME: | Titanium Mesh |
| CLASSIFICATION NAME: | Per CFR 21, §888.3060: Implant, fixation, spinal<br>intervertebral body fixation orthosis devices |
| PRODUCT CLASSIFICATION: | Class II |
| DEVICE PRODUCT CODE: | MQP |
| PREDICATE DEVICE: | (K003275) SynMesh™ Spacer System<br>(K003709) Surgical Dynamics™<br>Mesh Cage System<br>(K003043) DePuy AcroMed™ Surgical Titanium<br>Mesh™ System |
| DEVICE DESCRIPTION: | The Titanium Mesh is a vertebral body<br>replacement system comprised of several different<br>cross-sectional shaped implants with various<br>heights. The different cross-sectional shaped<br>shapes include: round, oval, oblong and kidney<br>(banana) shaped implants. The height of the<br>implants varies from 7mm to 130mm. In addition,<br>some of the implants are trapezoidal, i.e., the<br>posterior side of the implant is lower than the<br>anterior side of the implant. A cutting tool allows<br>for trimming of the implants to the desired height<br>at surgical site. The interior of the mesh is open<br>and provides a space that can be filled with bone<br>graft material. The sidewalls of the mesh are<br>perforated by several holes and allow for bone<br>fusion through the sidewalls of the mesh. There<br>are several ribs running longitudinally along the<br>internal walls of the mesh.<br>Standard and trapezoidal end caps that correspond<br>to the various cross-sectional shapes of meshes are<br>included in the system. The end caps are placed on |

Titanium Mesh 510(k) Summary of Safety and Effectiveness

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242
k032371
top of and supported by the longitudinal ribs located
at the internal wall of the mesh. Also the end caps
have prongs that provide a friction-locking feature
between the caps and the ribs of the mesh. The end
caps are manually pressed into the mesh. Serrations
on the superior/inferior surface of the end caps
provide stability and prevent movement of the
implant.

The Titanium Mesh System is intended for use with
supplemental internal fixation spinal systems.

INTENDED USE:
The Titanium Mesh System is indicated for use in
the thoracolumbar spine (T1-L5) to replace a
collapsed, damaged, or unstable vertebral body due
to tumor or trauma (i.e. fracture), to achieve anterior
decompression of the spinal cord and other neutral
tissues, and to restore the height of a collapsed
vertebral body. The Titanium Mesh is designed to
restore the biomechanical integrity of the anterior,
middle, and posterior spinal column even in the
absence of fusion for a prolonged period

BASIS OF
SUBSTANTIAL
EQUIVALENCE:
The Titanium Mesh System is similar in
indications, material and design to the SynMesh™
Spacer System (K003275), the Surgical Dynamics™
Mesh Cage System (K003709) and the DePuy
AcroMed™ Surgical Titanium Mesh™ System
(K003043).

MATERIALS:
The Titanium Mesh System is manufactured from
surgical grade titanium alloy as described by
ASTM F-1108 (Ti-6Al-4V).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. In the center of the seal is an abstract symbol that resembles three parallel lines above a wavy line.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 2 2004

Ms. Kimberly L. Pruitt Clinical Research Associate Encore Medical I .. P. 9800 Metric Boulevard Austin, Texas 78758

Re: K032371

Trade/Device Name: Titanium Mesh System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: January 23, 2004 Received: January 26, 2004

Dear Ms. Pruitt:

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 I'DA'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. Kimberly L. Pruitt

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in your e FDA finding of substantial equivalence of your device to a legally promance neticate 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/dsma/dsmamain.html

Sincercly vours.

L-Mark N. Milburn

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| 510(k) Number (if known): | | K032371 - | | | - while and the count of the count of the count of the first and while the first and while the first and other the collection, | Comments of the Concession Concession in Concession |
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Titanium Mesh System Device Name:

Indications For Use:

## Titanium Mesh System Indications For Use

The Titanium Mesh System is indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture), to achieve anterior decompression of the spinal cord and other neutral tissues, and to restore the height of a collapsed vertebral body. The Titanium Mesh is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use צ (per 21 CFR 801.109)

OR

Over-The-Counter Use *_*_
(Optional Format 1-2-96)
Mark n Milkeum

(Division Sign-Division of General, Restorative, and Neurological Devices

510(K) Number K032371