DEVEX MESH SYSTEM

K023835 · Depuyacromed · MQP · Jan 29, 2003 · Orthopedic

Device Facts

• Record ID: K023835
• Device Name: DEVEX MESH SYSTEM
• Applicant: Depuyacromed
• Product Code: MQP · Orthopedic
• Decision Date: Jan 29, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Devex Mesh System is a spinal intervertebral body fixation orthosis; used to replace diseased or fractured vertebral bodies in the thoracolumbar spine (T1-L5). Device provides structural support to restore vertebral height and biomechanical integrity of the spinal column. Intended for use in conjunction with supplemental internal fixation systems (e.g., titanium plates or rods). Operated by surgeons in a clinical/surgical setting. Benefits include spinal cord decompression and stabilization of the anterior, middle, and posterior spinal column.

Clinical Evidence

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

Technological Characteristics

Material: Titanium alloy (Ti-6Al-4V). Form factor: Mesh-based vertebral body replacement cage. 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 tumor resection/excision or thoracic/lumbar 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, K020522)
• Stackable Cage System (K990148, K001340)

Submission Summary (Full Text)

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## VIII. 510(k) Summary

K023835
Page 1 of 1

| SUBMITTER: | DePuy AcroMed"), Inc. |
|------------|----------------------------|
| | 325 Paramount Drive |
| | Raynham, MA 02767-0350 USA |

JAN 2 9 2003

CONTACT PERSON: Karen F. Jurczak

November 15, 2002 DATE PREPARED:

Devex Mesh™ System PROPRIETARY NAME:

CLASSIFICATION NAME: Implant, fixation device Spinal intervertebral body fixation orthosis device

PREDICATE DEVICE Surgical Titanium Mesh System (K003043, K020522) Stackable Cage System (K990148, K001340)

The Devex Mesh System is indicated for use in the INTENDED USE: 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 Devex Mesh System is also indicated for treating fractures of the thoracic and lumbar spine.

> The Devex 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 Devex Miesh 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).

MATERIALS:

Titanium alloy (Ti-6Al-4V)

PERFORMANCE DATA:

Biomechanical testing, including static axial compression and dynamic axial compression, were conducted.

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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" arranged around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing to the right, with flowing lines suggesting movement or energy.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 9 2003

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

Re: K023835

Trade/Device Name: Devex Mesh™ System Regulation Number: 21 CFR 888.3060 Regulation Name: Vertebral Body Replacement Device Regulatory Class: Class II Product Code: MQP Dated: January 8, 2003 Received: January 9, 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. Iisting 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 - Mr. Frank Maas

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" (21 CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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,

sincerely, yours,

Mark N Millman

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): ____________________________________________________________________________________________________________________________________________________

Page 1 of 1

Devex Mesh™ System Device Name:

Indications For Use:

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

The Devex 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 Devex Mesh System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Devex 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).

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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

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Division

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510(k) Number: K023835