MODIFICATION TO SURGICAL TITANIUM MESH SYSTEM

K020522 · Depuyacromed · MQP · Mar 21, 2002 · Orthopedic

Device Facts

• Record ID: K020522
• Device Name: MODIFICATION TO SURGICAL TITANIUM MESH SYSTEM
• Applicant: Depuyacromed
• Product Code: MQP · Orthopedic
• Decision Date: Mar 21, 2002
• 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 and Profile).

Device Story

Surgical Titanium Mesh System is a spinal implant used to replace diseased or fractured vertebral bodies in the thoracolumbar spine (T1-L5). Device restores biomechanical integrity of spinal column; provides anterior decompression of spinal cord and neural tissues; restores height of collapsed vertebral bodies. Intended for use in conjunction with supplemental internal fixation systems (e.g., titanium plates or rods). Implanted by surgeons in clinical/surgical settings. Benefits include structural support and stabilization of the spine following resection or trauma.

Clinical Evidence

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

Technological Characteristics

Constructed from Commercially Pure (CP) Titanium and Titanium alloy (Ti-6Al-4V). Device is a mesh-based vertebral body replacement implant. Designed for use with supplemental internal fixation systems. No software or electronic components.

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 Dynamics Mesh Cage System (K003709)

Submission Summary (Full Text)

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Surgical Titanium Mesh™ System

:

Comments of Children

ﭘ State of the country of the count

| IX. 510(k) Summary | |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTER: | DePuy AcroMed™, Inc.<br>325 Paramount Drive<br>Raynham, MA 02767-0350 USA<br>MAR 21 2002 |
| CONTACT PERSON: | Karen F. Jurczak |
| DATE PREPARED: | February 15, 2002 |
| 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)<br>Surgical Dynamics Mesh Cage System (K003709) |
| 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.<br><br>The Surgical Titanium Mesh System is also indicated for<br>treating fractures of the thoracic and lumbar spine.<br><br>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.<br><br>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 and Profile). |
| MATERIALS: | Commercially Pure (CP) Titanium<br>Titanium alloy (Ti-6Al-4V) |
| PERFORMANCE DATA: | Biomechanical testing, including static axial compression<br>and dynamic axial compression, were conducted. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three abstract human figures or profiles facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re:

K020522 Trade Name: Surgical Titanium Mesh System Regulation Number: 888.3060 Regulation Name: Vertebral Body Replacement Device Class: II Product Code: MQP Dated: February 15, 2002 Received: February 19, 2002

Dear Mr. Maas:

We have reviewed your Section 510(k) notification of intent to market the device referenced above we have reviewed your Society is substantially equivalent (for the indications for use stated in allo we have determined the device is substantially of the enaments on on the enactment alte the Medical Device Amendments, or to devices that have been reclassified in accordance with the or the Medical Dovice I michaments, or ad Cosmetic Act (Act). You may, therefore, market the provisions of the roderal rood, Dreg, and visions of the Act. The general controls provisions of the device, subject to the general ecistration, 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 (Premarket If your device is olassified (500 above) aitional controls. Existing major regulations affecting your Approval), it thay be subject to back as a substions, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice equirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requirement, as set form in the Quant) "hough periodic (QS) inspections, the Food and Drug regulation (FDA) will verify such assumptions. Failure to comply with the GMP regulation Administration (1 Dry Prify Pactives, FDA may publish further announcements concerning may result in the Federal Register. Please note: this response to your premarket notification your device in the Peachar 100 might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Frank Maas

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed noutication. THC PDA miding of substantial vour 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) additionally 007.10 for in This anaghoon the promotion and advertising of your device, please 574-4639. Traditionally, 10. quests [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information "Wisolanding of reference to premation in the Division of Small Manufacturers on your responsibilities ander the rice may of at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Mark A. Williams

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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## IV. Indications for Use .

510(k) Number (if known):

Surgical Titanium Mesh 100 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 and Profile).

Mark N. Milken

(Division Sig-Off)
Division of General, Restorative
and Neurological Devices

510(k) Number _

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Over-The-Counter Use: Prescription Use: (Per 21 CFR 801.109)

DePuy AcroMed, Inc. 510(K)