PEEK CAS

K050861 · Interpore Cross Intl. · MQP · May 27, 2005 · Orthopedic

Device Facts

• Record ID: K050861
• Device Name: PEEK CAS
• Applicant: Interpore Cross Intl.
• Product Code: MQP · Orthopedic
• Decision Date: May 27, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PEEK CAS is indicated for use in the thoracolumbar spine (i.e., TI to L5) for partial replacement of 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 PEEK CAS is also indicated for partial vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The PEEK CAS 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

PEEK CAS is a curved, implantable vertebral body replacement device. Constructed from medical-grade PEEK OPTIMA LT1; features pyramidal teeth on superior/inferior ends to resist expulsion; includes tantalum markers for radiographic visibility. Device is open in the transverse plane to allow surgeon to pack with bone graft; contains anterior-posterior holes to facilitate bone growth. Available in flat or lordotic configurations. Implanted by surgeons in clinical settings to restore biomechanical integrity of the spinal column following resection of diseased vertebrae or fractures. Radiolucent material allows post-operative visualization of bone growth at the defect site.

Clinical Evidence

No clinical data. Substantial equivalence based on biomechanical performance and material similarity.

Technological Characteristics

Material: PEEK OPTIMA LT1 (ASTM F-2026). Markers: Tantalum (ASTM F-560). Design: Curved implant with pyramidal teeth, transverse opening for bone graft, and anterior-posterior holes. Radiolucent. No energy source or software.

Indications for Use

Indicated for patients requiring partial 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

• Interpore Cross Expandable PEEK VBR (K040928)
• Interpore Cross NEXUS (K040168)

Submission Summary (Full Text)

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# 510(k) SUMMARY

K050861 Page I of I

### SUBMITTED BY

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

Date Prepared: April 4, 2005

#### 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 Device Class II MOP PEEK CAS

#### PREDICATE DEVICE

Interpore Cross Expandable PEEK VBR (K040928) Interpore Cross NEXUS (K040168)

#### INDICATIONS-FOR-USE

The PEEK CAS is indicated for use in the thoracolumbar spine (i.e., TI to L5) for partial replacement of 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 PEEK CAS is also indicated for partial vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The PEEK CAS 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 PEEK CAS is a curved implant constructed of Polyetheretherketone, medical grade (PEEK OPTIMA™ LT1) as described by ASTM F-2026. The pyramidal teeth on the superior and inferior ends resist expulsion in all directions. The device is available in flat or lordotic angles. The device is open in the transverse plane to allow the surgeon to pack the device with bone graft prior to insertion. There are also holes through the anterior-posterior direction to allow for additional bone growth through the device. The tantalum markers used for this product are made to the voluntary standard ASTM F-560. 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 PEEK CAS is considered substantially equivalent to the legally marketed predicate device.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 7 2005

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

Re: K050861

Trade/Device Name: PEEK (CAS) Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: May 5, 2005 Received: May 6, 2005

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 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

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/industry/support/index.html.

Sincerely yours,

A. Hyat Clurdie

C. Provost, Ph.D. Acting 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): K050861

Device Name: PEEK CAS

## Indications-For-Use:

The PEEK CAS is indicated for use in the thoracolumbar spine (i.e., T1 to L5) for partial replacement of 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 PEEK CAS is also indicated for partial vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The PEEK CAS 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.

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)

Stypt. Burch

Page 1 of 1

(Division Division of General, Restorative. and Neurological Devices

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