MODIFICATION TO GEO STRUCTURE

K020048 · Interpore Cross Intl. · MQP · Feb 6, 2002 · Orthopedic

Device Facts

• Record ID: K020048
• Device Name: MODIFICATION TO GEO STRUCTURE
• Applicant: Interpore Cross Intl.
• Product Code: MQP · Orthopedic
• Decision Date: Feb 6, 2002
• 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 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 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 (T1-L5) to replace diseased vertebrae resected for tumors or to treat fractures. Device restores biomechanical integrity of anterior, middle, and posterior spinal columns; functions even without fusion for prolonged periods. Implanted by surgeons in clinical settings. Provides structural support to spinal column; facilitates decompression of neural tissues. Benefits include restoration of spinal height and stability.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Vertebral body replacement device; material: surgical implant grade titanium alloy (Ti 6Al 4V) per ASTM F-1108; satin finish surface; available in various shapes and sizes; provided sterile or nonsterile.

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.

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

• GEO™ Structure (K010530)

Submission Summary (Full Text)

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## 510(k) SUMMARY

K020048

### SUBMITTED BY

2/6/02

Lynn Rodarti Manager, Regulatory and Clinical Affairs Interpore Cross International 181 Technology Drive Irvine, California 92618

[phone]

January 4, 2002

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

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

#### PREDICATE DEVICE

The predicate device is the GEO™ Structure (K010530).

#### INDICATIONS-FOR-USE

The GEO Structure is indicated for use in the thoracolumbar spine (i.e., T1 to LS) to replace a diseased vertebral body resected or excised for the treatment of turnors 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 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.

#### DISCUSSION OF NONCLINICAL TESTS

Data regarding the functional performance of the proposed GEO Structure has been generated and indicates that the proposed GEO Structure meets or exceeds all functional requirements and supports its suitability for use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 6 2002

Ms. Lynn M. Rodarti Manager, Clinical and Regulatory Affairs Interpore Cross International 181 Technology Drive Irvine, California 92618-2402

Re: K020048

Trade/Device Name: GEO™ Structure Regulation Number: 21 CFR §888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: January 4, 2002 Received: January 7, 2001

Dear Ms. Rodarti:

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.

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#### Page 2 - Ms. Lynn Rodarti

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.

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 vours.

R. Martin Milken

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

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K 02 0048

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# 510(k) Number (if known):

GEO Structure Device Name:

## Indications-For-Use:

The GEO Structure is indicated for use in the thoracolumbar spine (i.e., 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 le admore 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.

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

Mark A Millican

Division Sign-Off) (Division Sigi-Ori)
Division of General, Resions Divisiourological Devices 1620048

510(k) Number .

Prescription Use (PER 21 CFR 801.109)

96)

OR

Over-The-Counter Use

(Optional Format 1-2-

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