SURGICAL TITANIUM MESH SYSTEM

K030249 · Depuyacromed · MQP · Feb 14, 2003 · Orthopedic

Device Facts

• Record ID: K030249
• Device Name: SURGICAL TITANIUM MESH SYSTEM
• Applicant: Depuyacromed
• Product Code: MQP · Orthopedic
• Decision Date: Feb 14, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Surgical Titanium Mesh System is indicated for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Surgical Titanium Mesh System is also indicated for treating fractures of the thoracic and lumbar spine. The Surgical Titanium Mesh System 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. The Surgical Titanium Mesh System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Surgical Titanium Mesh System include DePuy AcroMed titanium plate or rod systems (e.g. Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, Monarch and Profile).

Device Story

Surgical Titanium Mesh System is an implantable fixation device for thoracolumbar spine (T1-L5). Used by surgeons to replace diseased vertebral bodies resected for tumors or to treat spinal fractures. Device restores height of collapsed vertebral bodies and biomechanical integrity of spinal column. Must be used with supplemental internal fixation systems (e.g., titanium plates or rods).

Clinical Evidence

Bench testing only. Biomechanical testing, including static axial compression and dynamic axial compression, was conducted to demonstrate performance.

Technological Characteristics

Material: Titanium alloy (Ti-6Al-4V). Form factor: Mesh system for vertebral body replacement. Energy source: None (mechanical implant). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring vertebral body replacement in the thoracolumbar spine (T1-L5) due to tumors or fractures. Used to achieve anterior decompression and restore vertebral height. Requires use with supplemental internal 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

• Surgical Titanium Mesh System (K003043)
• Surgical Titanium Mesh System (K020522)

Submission Summary (Full Text)

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Surgical Titanium Mesh™ System

## VIII. 510(k) Summary

| SUBMITTER: | DePuy AcroMed ^™ , Inc.<br>325 Paramount Drive<br>Raynham, MA 02767-0350 USA | FEB 1 4 2003 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| CONTACT PERSON: | Karen F. Jurczak | |
| DATE PREPARED: | January 24, 2003 | |
| PROPRIETARY NAME: | Surgical Titanium Mesh ^™ System | |
| CLASSIFICATION NAME: | Implant, fixation device<br>Spinal intervertebral body fixation orthosis device | |
| PREDICATE DEVICE: | Surgical Titanium Mesh System (K003043, K020522) | |
| INTENDED USE: | The Surgical Titanium Mesh System is indicated for use in<br>the thoracolumbar spine (T1-L5) to replace a diseased<br>vertebral body resected or excised for the treatment of<br>tumors, to achieve anterior decompression of the spinal<br>cord and neural tissues, and to restore the height of a<br>collapsed vertebral body. | |
| | The Surgical Titanium Mesh System is also indicated for<br>treating fractures of the thoracic and lumbar spine. | |
| | The Surgical Titanium Mesh System is designed to restore<br>the biomechanical integrity of the anterior, middle, and<br>posterior spinal column even in the absence of fusion for a<br>prolonged period. | |
| | The Surgical Titanium Mesh System is intended for use<br>with supplemental internal fixation. The supplemental<br>internal fixation systems that may be used with the<br>Surgical Titanium Mesh System include DePuy AcroMed<br>titanium plate or rod systems (e.g. Kaneda SR, University<br>Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, Monarch and<br>Profile). | |
| MATERIALS: | Titanium alloy (Ti-6Al-4V) | |
| PERFORMANCE<br>DATA: | Biomechanical testing, including static axial compression<br>and dynamic axial compression, were conducted. | |

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Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them, resembling a bird or flowing water. The logo is rendered in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 4 2003

Mr. Frank Maas Director, Regulatory Affairs DePuy Acromed 325 Paramount Drive Raynham, Massachusetts 02767-0350

K030249 Re:

> Trade Name: Titanium Mesh System - Addition of Components Regulation Number: 21 CFR 888.3060 Regulation Name: Vertebral Body Replacement Device Regulatory Class: II Product Code: MQP Dated: January 23, 2003 Received: January 24, 2003

Dear Mr. Maas:

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.

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Page 2 - Mr. Frank Maas

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. 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/dsma/dsmamain.html

Sincerely yours,

Mark M. Millhuser

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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## III. Indications for Use

510(k) Number (if known): K030249

Surgical Titanium Mesh 10 System Device Name:

## Indications For Use:

The Surgical Titanium Mesh System is indicated for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.

The Surgical Titanium Mesh System is also indicated for treating fractures of the thoracic and lumbar spine.

The Surgical Titanium Mesh System 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.

The Surgical Titanium Mesh System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Surgical Titanium Mesh System include DePuy AcroMed titanium plate or rod systems (e.g. Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, Monarch and Profile).

for Mark n Millerson
Division Sign-Off

Division of
and Neurology

510(k) Number: K03,0249

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use: | |
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| (Per 21 CFR 801.109) | |

OR Over-The-Counter Use: