SURGICAL TITANIUM MESH SYSTEM

K003043 · Depuyacromed · MQP · May 8, 2001 · Orthopedic

Device Facts

• Record ID: K003043
• Device Name: SURGICAL TITANIUM MESH SYSTEM
• Applicant: Depuyacromed
• Product Code: MQP · Orthopedic
• Decision Date: May 8, 2001
• Decision: SESE
• Submission Type: Traditional
• 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. Bone graft material is recommended to be packed inside of the mesh cage prior to implantation. 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; spinal implant for vertebral body replacement. Device consists of mesh cage; packed with bone graft; implanted in thoracolumbar spine (T1-L5) to replace diseased or fractured vertebrae. Used by surgeons in clinical settings to restore spinal height and biomechanical integrity. Requires supplemental internal fixation (e.g., titanium plates/rods). Benefits include spinal cord decompression and structural support.

Clinical Evidence

Clinical data provided to demonstrate performance in patients with spine tumors. Bench testing included static and dynamic axial compression.

Technological Characteristics

Materials: Commercially Pure (CP) Titanium and Titanium alloy (Ti-6Al-4V). Form factor: Mesh cage system. Requires supplemental internal fixation. No software or electronic components.

Indications for Use

Indicated for patients with diseased vertebral bodies (tumors) or fractures in the thoracolumbar spine (T1-L5) requiring vertebral body replacement, anterior decompression, or height restoration. 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

• Stackable Cage System (K990148)
• Rezaian Spinal Fixator (K841189)

Submission Summary (Full Text)

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| IX. 510(k) Summary | MAY - 8 2001 | K003043 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| SUBMITTER: | DePuy AcroMed ™, Inc.<br>325 Paramount Drive<br>Raynham, MA 02767-0350 USA | |
| CONTACT PERSON: | Karen F. Jurczak | |
| DATE PREPARED: | April 13, 2001 | |
| PROPRIETARY NAME: | Surgical Titanium Mesh™ System | |
| CLASSIFICATION NAME: | Implant, fixation device<br>Spinal intervertebral body fixation orthosis device | |
| PREDICATE DEVICE: | Stackable Cage System (K990148)<br>Rezaian Spinal Fixator (K841189) | |
| 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. Bone graft material is recommended to<br>be packed inside of the mesh cage prior to implantation.<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<br>DATA: | Biomechanical testing, including static axial compression<br>and dynamic axial compression, were conducted.<br>Clinical data were provided to demonstrate the<br>performance of the device in patients with spine tumors. | |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white 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 top half of the circle. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract human form or a caduceus without the snake, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 8 2001

Ms. Karen F. Jurczak Regulatory Affairs Associate DePuy AcroMed 325 Paramount Drive Raynham, Massachusetts 02767-0350

Re: K003043

Trade/Device Name: Surgical Titanium Mesh System Regulation Number: Unclassified Product Code: MQP Dated: April 13, 2001 Received: April 16, 2001

Dear Ms. Jurczak:

We have reviewed your Section 510(k) notification of intent to market the device referenced we nave reviewed your becaon 910(x) health in the substantially equivalent (for the indications for use above and we nave determined the actrected predicate devices marketed in interstate commerce stated in the enclosure) to legally manufacted ptthe Medical Device Amendments, or to devices that provision in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act (Act). Tou may, atererors, and controls provisions of the Act include requirements for annual provisions of the Act. "The general countincturing 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 Approval), it may be subject to such additional controls. Existing major regulations (1 remance rippioval), it they of our control in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mspections, the Food and Desult in regulatory action. In addition, FDA may publish Compy with ans Concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you 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 - Ms. Karen F. Jurczak

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 notification. The I Dri imaling of succion 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 and If you desire specific advice for your as ic devices), please contact the Office of Compliance at additionally 607.10 for in Thio diagnestions on the promotion and advertising of your device, [phone]. Rudinonary, 18. quise at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small
information on your responsibilities under the Act may be obtained in 16507 watc Illionnation on your responsibilities and more [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

rominhellon propri

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™ 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. Bone graft material is recommended to be packed inside of the mesh cage prior to implantation.

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).

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

510(k) Number K002043

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

| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| Prescription Use: | <div style="text-decoration: line-through;"></div> |
| | OR Over-The-Counter |
| Use: | |
| (Per 21 CFR 801.109) | |

DePuy AcroMed Inc
Page B 2uy AcroMed, Inc. Indications For Use