TITANIUM MESH IMPLANT

K041407 · Interpore Cross Intl. · MQP · Dec 29, 2004 · Orthopedic

Device Facts

• Record ID: K041407
• Device Name: TITANIUM MESH IMPLANT
• Applicant: Interpore Cross Intl.
• Product Code: MQP · Orthopedic
• Decision Date: Dec 29, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Titanium Mesh Implant is indicated for use in the thoracolumbar spine (T1 to LS) for total replacement of diseased vertebral body(ies) resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Titanium Mesh Implant is also indicated for total vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The Titanium Mesh Implant 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 Titanium Mesh Implant is intended to be used with supplemental internal fixation. The supplemental fixation system that must be used with this implant is the Synergy Spinal System. In addition, the Titanium Mesh Implant is intended for use with bone graft.

Device Story

Titanium Mesh Implant; hollow cylindrical tube; commercially pure titanium. Used for total vertebral body replacement in thoracolumbar spine (T1-L5) following tumor resection or fracture. Implant features concentric oval openings for trimming and circular grooves for length adjustment. Device provides structural support to restore spinal column biomechanical integrity. Requires use with Synergy Spinal System (supplemental internal fixation) and bone graft. Implanted by surgeons in clinical settings to achieve anterior decompression and height restoration. Benefits include spinal stabilization and neural tissue decompression.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Hollow cylindrical tube; commercially pure (CP) titanium per ASTM F-67. Features concentric oval openings and circular grooves for surgical customization. Mechanical fixation device; non-software; non-powered.

Indications for Use

Indicated for patients requiring total vertebral body replacement in the thoracolumbar spine (T1-L5) due to tumors or fractures. Must be used with supplemental internal fixation (Synergy Spinal System) and bone graft.

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

• DePuy Acromed Surgical Titanium Mesh (K003043 and K020522)

Submission Summary (Full Text)

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### 510(k) SUMMARY

#### SUBMITTED BY

Wendy Spielberger, RAC Lead Regulatory and Clinical Affairs Staff Interpore Cross International 181 Technology Drive Irvine, California 92618 [phone]

Datc Prepared: May 26, 2004

#### CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME

Classification Name: Common/Usual Name: Product Classification: Product Code: Proprietary Name:

Spinal Intervertebral Fixation Orthosis Vertebral Body Replacement Class II MOP Titanium Mesh Implant

#### PREDICATE DEVICE

DePuy Acromed Surgical Titanium Mesh (K003043 and K020522)

#### INTENDED USE

The Titanium Mesh Implant is indicated for use in the thoracolumbar spine (T1 to LS) for total replacement of diseased vertebral body(ies) resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Titanium Mesh Implant is also indicated for total vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The Titanium Mesh Implant 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 Titanium Mesh Implant is intended to be used with supplemental internal fixation. The supplemental fixation system that must be used with this implant is the Synergy Spinal System. In addition, the Titanium Mesh Implant is intended for use with bone graft.

#### DEVICE DESCRIPTION

The Titanium Mesh Implant is a hollow cylindrical tube made from commercially pure (CP) titanium (ASTM F-67). The sides of the cylinder implants contain concentric oval patterned openings. These openings allow the surgeon to trim the cylinder to the desired length at a pre-specified angle relative to the longitudinal axis of the cylinder. The external surface of the implant contains concentric circular grooves perpendicular to the axis of the cylinder which provides a guide in the event that a perpendicular end is desired.

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# COMPARISON TO THE PREDICATE DEVICE

Based on the same indications for use, intended use, similarity in materials of construction and equivalent biomechanical performance, the Titanium Mesh Implant is considered substantially equivalent to the legally marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three horizontal lines extending from its head, representing the department's mission to protect and promote the health and well-being of Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 9 2004

Ms. Wendy Spielberger Lead Regulatory and Clinical Affairs Staff Interpore Cross International 181 Technology Drive Irvine, California 92618-2402

Re: K041407

Trade/Device Name: Titanium Mesh Implant Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: December 15, 2004 Received: December 16, 2004

Dear Ms. Spielberger:

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 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 se 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. Wendy Spielberger

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 A. Wilkerson

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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## Indications for Use

510(k) Number (if known):

Titanium Mesh Implant Device Name:

#### Indications-For-Use:

The Titanium Mcsh Implant is indicated for use in the thoracolumbar spine (i.e., T1 to L5) for total replacement of diseased vertebral body(ies) resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and ncural tissues, and to restore the height of a collapsed vertebral body. The Titanium Mesh Implant is also indicated for total vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The Titanium Mesh Implant 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 Titanium Mesh Implant is intended to be used with supplemental internal fixation. The supplemental fixation system that must be used with this implant is the Synergy Spinal System. In addition, the Titanium Mesh Implant is intended for use with bone graft.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

**(Division Sign-Off)**

Division of General, Restorative,

and Neurological Devices

510(k) Number K041407