SMALL STATURE SPACERS

K063393 · Biomet Spine · MQP · Jun 25, 2007 · Orthopedic

Device Facts

• Record ID: K063393
• Device Name: SMALL STATURE SPACERS
• Applicant: Biomet Spine
• Product Code: MQP · Orthopedic
• Decision Date: Jun 25, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Small Stature Spacers are 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 Small Stature Spacers are also indicated for partial vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The Small Stature Spacers are 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

Small Stature Spacers are vertebral body replacement devices used in thoracolumbar spine surgery. Fabricated from polyetheretherketone (PEEK), these implants are inserted by surgeons to replace diseased or fractured vertebral bodies. The device functions to restore spinal height and biomechanical integrity, facilitating anterior decompression of neural tissues. It is intended for use in clinical settings by surgeons. The device provides structural support to the spinal column, potentially benefiting patients by stabilizing the spine and relieving pressure on neural structures.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Material: Polyetheretherketone (PEEK). Form factor: Vertebral body replacement spacer. Design is similar to the predicate device.

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/biomechanical integrity.

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

• ESL® PEEK-OPTIMA® Spine System (K061016)

Submission Summary (Full Text)

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K063393

# 510(k) Summary

Preparation Date: November 8, 2006 JUN 2 5 2007

Applicant/Sponsor: Biomet Spine

Contact Person: Debra L. Bing

Proprietary Name: Small Stature Spacers

Common Name: Vertebral Body Replacement Device

Classification Code/Name: Spinal Intervertebral Fixation Orthosis, 21 CFR 8888.3060

Product Code: MOP

### Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

- ESL® PEEK-OPTIMA® Spine System K061016 .
### Device Description:

The Small Stature Spacers are comprised of polyetheretherketone (PEEK) and are similar in design to the EBI ESL PEEK-OPTIMA® Spine System cleared in K061016.

### Indications for Use:

The Small Stature Spacers are 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 Small Stature Spacers are also indicated for partial vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The Small Stature Spacers are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.

Summary of Technologies: The technological characteristics of the Small Stature Spacers are the same as, or similar to, the predicate device.

Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the devices were functional within their intended use.

Clinical Testing: Clinical testing was not required for the predicate device. Therefore, this submission contains no clinical testing.

All trademarks are property of Biomet, Inc., except PEEK-OPTIMA®, which is the property of Invibio Biomaterial Solutions.

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Image /page/1/Picture/12 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.

JUN 2 5 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomet Spine % Biomet Manufacturing Corporation Ms. Susan Alexander Regulatory Specialist P.O. Box 587 Warsaw. Indiana 46581-0587

Re: K063393

Trade/Device Name: Small Stature Spacers Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: May 18, 2007 Received: May 21, 2007

Dear Ms. Alexander:

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. Susan Alexander

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/industry/support/index.html.

Sincerely yours.

Harbazo Muchup

Mark N. Melkerson 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

K063393 510(k) Number (if known):

Device Name: Small Stature Spacers

Indications For Use:

The Small Stature Spacers are 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 Small Stature Spacers are also indicated for partial vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The Small Stature Spacers are 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 YES (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NO (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)

Qabare Buerup

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

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510(k) Number k063393