MODIFICATION TO GEO STRUCTURE

K040168 · Interpore Cross Intl. · MQP · Apr 8, 2004 · Orthopedic

Device Facts

• Record ID: K040168
• Device Name: MODIFICATION TO GEO STRUCTURE
• Applicant: Interpore Cross Intl.
• Product Code: MQP · Orthopedic
• Decision Date: Apr 8, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GEO Structure is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace a diseased vertebral body 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 GEO Structure is also indicated for treating fractures of the thoracic and lumbar spine. The GEO Structure 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.

Device Story

GEO Structure is a vertebral body replacement implant used in thoracolumbar spine surgery. It replaces diseased or fractured vertebral bodies to restore spinal height and biomechanical integrity. The device is implanted by a surgeon during spinal procedures. It functions as a structural support for the anterior, middle, and posterior spinal column. It is manufactured from titanium alloy and is available in various shapes and sizes to accommodate patient anatomy. The device provides mechanical stabilization to the spinal column, potentially benefiting patients by relieving neural compression and restoring structural support.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and biomechanical performance characteristics.

Technological Characteristics

Material: Surgical implant grade titanium alloy (Ti 6Al 4V) per ASTM F-1108. Design: Vertebral body replacement implant with satin finish surface, available in various shapes and sizes. Sterilization: Provided sterile or non-sterile.

Indications for Use

Indicated for patients requiring vertebral body replacement in the thoracolumbar spine (T1-L5) due to tumors (following resection/excision) or fractures. Used to achieve anterior decompression of spinal cord/neural tissues and restore vertebral body height.

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.

Submission Summary (Full Text)

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# 510(k) SUMMARY

K040168
Page 1 of 1

### SUBMITTED BY

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

[phone]

January 23, 2004

This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR §807.92.

## CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME

Vertebral Body Replacement Classification Name: Common/Usual Name: Vertebral Body Replacement Product Classification: Class II GEO Structure™ Proprietary Name:

### PREDICATE DEVICE

Predicate device information is included in this premarket notification.

## INDICATIONS-FOR-USE

The GEO Structure is indicated for use in the thoracolumbar spine (i.c., T1 to LS) to replace a diseased vertebral body 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 GE() structure is also indicated for treating fractures of the thoracic and lumbar spine. The GEO Structure 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.

### DEVICE DESCRIPTION

The GEO Structure is a vertebral body replacement device manufactured from surgical implant grade titanium alloy as described by ASTM F-1108 (Ti 6Al 4V). The implant has a satin finish surface and is available in various shapes and sizes. The GEO Structure is provided either sterile or nonsterile.

### COMPARISON TO THE PREDICATE DEVICE

Based on the same indications for use, intended use, similarity in materials of construction and equivalent biomechanical performance, the GEO Structure is considered substantially equivalent to the legally marketed predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

APR - 8 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K040168

Trade/Device Name: GEO Structure™ Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: March 9, 2004 Received: March 11, 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 for abo band in 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 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 - Ms. Wendy Spielberger, RAC

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 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. Millam

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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# 510(k) Number (if known): K 0401 68

GEO Structure Device Name:

## Indications-For-Use:

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(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODF.)

Prescription Use
Use
(PER 21 CFR 801.109) X

for Mark n Millham

Over-The-Counter

(Optional Format 1-2-96)

Division of General, Restorat. and Neurological Devices

510(k) Number K040168