EXPANDABLE PEEK VBR IMPLANT

K040928 · Interpore Cross Intl. · MQP · Aug 27, 2004 · Orthopedic

Device Facts

• Record ID: K040928
• Device Name: EXPANDABLE PEEK VBR IMPLANT
• Applicant: Interpore Cross Intl.
• Product Code: MQP · Orthopedic
• Decision Date: Aug 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Expandable PEEK VBR Implant 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 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 Expandable PEEK VBR Implant is also indicated for treating fractures of the thoracic and lumbar spine. The Expandable PEEK VBR 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.

Device Story

Expandable PEEK VBR Implant is a spinal orthosis for thoracolumbar (T1-L5) vertebral body replacement. Device is inserted into the surgical site between vertebral bodies; features a ratcheting mechanism for expansion to restore height; includes a reinforcement clip to maintain height post-expansion. Radiolucent PEEK material allows radiographic visualization of bone growth. Used by surgeons in clinical settings to treat tumors or fractures; restores biomechanical integrity of spinal column. Benefits include spinal cord decompression and structural support.

Clinical Evidence

No clinical data; substantial equivalence based on bench testing and material similarity.

Technological Characteristics

Constructed of medical grade PEEK OPTIMA LTI (ASTM F-2026) with tantalum markers (ASTM F-560). Expandable design via ratcheting mechanism with reinforcement clip. Radiolucent. Mechanical device; no software or energy source.

Indications for Use

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

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)

{0}------------------------------------------------

K04-09128

# AUG 2 7 2004

### 510(k) SUMMARY

#### SUBMITTED BY

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

## CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME

| Classification Name: | Vertebral Body Replacement Device |
|-------------------------|-----------------------------------|
| Common/Usual Name: | Vertebral Body Replacement Device |
| Product Classification: | Class II |
| Proprietary Name: | Expandable PEEK VBR Implant |

#### PREDICATE DEVICE

Predicate device information is included in this premarket notification.

#### INDICATIONS-FOR-USE

The Expandable PEEK VBR Implant 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 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 Expandable PEEK VBR Implant is also indicated for treating fractures of the thoracic and lumbar spine. The Expandable PEEK VBR 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.

#### DEVICE DESCRIPTION

The Expandable PEEK VBR Implant is an expandable device constructed of Polyetheretherketone, medical grade (PEEK OPTIMA™ LTI) as described by ASTM F-2026. The tantalum markers used for this product are made to the voluntary standard ASTM F-560. The Expandable PEEK VBR Implant is inserted between vertebral bodies in the posterior thoracolumbar spine from T1 to LS. Following insertion into the surgical site, the implant may be left undistracted or may be expanded via a ratcheting mechanism. When expanded, a reinforcement clip is inserted into the implant to aid in maintaining height. The radiolucent PEEK material allows visualization of the defect site on radiograph to assess bone growth.

#### COMPARISON TO THE PREDICATE DEVICE

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

{1}------------------------------------------------

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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing segments.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 27 2004

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

Re: K040928

Trade/Device Name: Expandable PEEK VBR Implant Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: August 13, 2004 Received: August 16, 2004

Dear Ms. Spielberger:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorosale) to regard) the enactment date of the Medical Device Amendments, or to commence pror to may 20, 1978, the ensordance with the provisions of the Federal Food, Drug, devices that have been routes and in assee approval of a premarket approval application (PMA). alle Costience Act (71ct) that to nov requent to the general controls provisions of the Act. The I ou may, merceive, manel the Act include requirements for annual registration, listing of general connologic provisions 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 If your device is classified (600 a00 10) als. Existing major regulations affecting your device can Inay be subject to suell additions, Title 21, Parts 800 to 898. In addition, FDA may oublish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I teast of advised that I DTT blisdains of our device complies with other requirements of the Act that I Dri has intatutes and regulations administered by other Federal agencies. You must of any I cuchares und regulations and winned to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI It Fart 6077, lacemig (21 CFR Part 820); and if applicable, the electronic form in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.

{2}------------------------------------------------

Page 2 - Wendy Spielberger, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin mailtoning of substantial equivalence of your device to a legally premits touritication: The Prix manigstification 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 If you desire specific advice for your ac 1100 594-4692. Also, please note the regulation entitled, colliati the Office of Comphalled as (50 t notification" (21CFR Part 807.97). You may obtain Misblanding of Crefeired to premainters in the Act from the Division of Small other general information on your responsible in total free number [phone] or
Manufacturers, International and Consumer Assistance at its to the success in brokey Manufacturers, micrnational and Ochess http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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

{3}------------------------------------------------

# Indications for Use

K040928 510(k) Number (if known):

Expandable PEEK VBR Device Name:

## Indications-For-Use:

The Expandable PEEK VBR Implant is indicated for use in the thoracolumbar spine (i.e., T1 I TIC Expandable I EER VDR anspiral body resected or excised for the treatment of tumors in to LD replace a anseason version of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Expandable PEEK VBR Implant is also inclicated for treating fractures of the thoracic and lumbar spine. The Expandable PEEK multiated for treating tractares of as a biomechanical integrity of the anterior, middle and v DIC implain is absence of the absence of fusion for a prolonged period.

| Prescription Use | <b>X</b> |
|-----------------------------|----------|
| (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)

***_*****_ and**__, signature, Mark N. Millman

(Division Sign- Iff Division of General, Restorative, and Neurological Devices

Page 1 of 1

510(K) Number K040928