OSSTAPLE, OSSPLATE, OSSFORCE

K061385 · Biomedical Enterprises, Inc. · KWQ · May 30, 2007 · Orthopedic

Device Facts

• Record ID: K061385
• Device Name: OSSTAPLE, OSSPLATE, OSSFORCE
• Applicant: Biomedical Enterprises, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: May 30, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For use in conjunction with traditional rigid fixation in cervical fusion procedures as a means to maintain the relative position of bony tissue such as allografts. This device is for use with traditional rigid fixation devices such as the Ransford Loop, Hartshill rectangles, cerclage wiring or other legally marketed cervical spine stabilization device. This device is not intended to be used alone for load bearing applications.

Device Story

OSStaple™ system consists of two-prong Nitinol staples; used in cervical fusion procedures to maintain bony tissue/allograft position. Device functions as adjunct to traditional rigid fixation (e.g., wiring, loops). Operation involves OSSforce™ Controller applying electrical current to staple; Joule heating effect triggers Nitinol shape memory; prongs deflect inward and "S" back contracts to provide compression/retention. Controller circuitry limits current/time to prevent tissue damage. Used by surgeons in clinical/OR settings. Benefits include enhanced stability of bone grafts during fusion.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics, material composition, and established performance of the OSSforce™ Controller heating unit.

Technological Characteristics

Two-prong staples fabricated from Nitinol (shape memory alloy). System includes OSSforce™ Controller for electrical heating. Principle: Joule heating effect induces austenitic phase transition for compression. Controller features circuitry to limit current and duration to prevent thermal tissue damage. Standalone controller unit; manual application.

Indications for Use

Indicated for use in cervical fusion procedures as an adjunct to traditional rigid fixation (e.g., Ransford Loop, Hartshill rectangles, cerclage wiring) to maintain relative position of bony tissue/allografts. Not for standalone load-bearing use.

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

• Medicrea C-JAWS Cervical Compressive Mini Frame (K062181)
• Depuy BOWTI™ Anterior Buttress Staple (K021039)

Reference Devices

• OSSforce™ Controller (K023203)
• OSSforce™ Controller (K023486)
• OSSforce™ Controller (K023488)

Submission Summary (Full Text)

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

K061385

# APPENDIX III (510(k) Summary)

# MAY 3 0 2007

Product:

OSStaple™ Staple System

BioMedical Enterprises, Inc. (BME) intends to introduce additional indications for the OSStaple™ System consisting of shape memory Nitinol staples (the "OSStaple™ and "OSSplate™") and accessories for setting and warming the staples to achieve compression.

## Submittor Information 2.

BioMedical Enterprises, Inc. 14785 Omicron Drive, Ste. 205 San Antonio, Texas 78245 Telephone: [phone] Contact: Dr. W. Casey Fox (CEO)

Date Prepared: August 8, 2006

- b. Classification name: Appliance, Fixation, Spinal Intervertebral Body Common/Usual Name: Spinal Intervertebral body fixation orthosis Proprietary Name: OSStaple™ Staple System Product Code: KWQ Regulation Number: 888,3060
#### Intended Use: c.

a personal personal personale per mensione mensivere mart provincia per conservative provinsi se provincia per propositivo provincia por pro
vi

a produktion of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments

Additional indications for the OSStaple™ are:

For use in conjunction with traditional rigid fixation in cervical fusion procedures as a means to maintain the relative position of bony tissue such as allografts. This device is for use with traditional rigid fixation devices such as the Ransford Loop, Hartshill rectangles, cerclage wiring or other legally marketed cervical spine stabilization device. This device is not intended to be used alone for load bearing applications.

Device Description d.

The OSStaple™ Staple system cons`ists of two prong staples fabricated from Nitinol. The staple's prongs are parallel during insertion. Application of an electrical current from the OSSforce™ Controller to the staple causes the staple prongs to deflect inward and the "S" shaped back to contract until constrained. This inward deflection and contraction causes staple retention. This device is for use with traditional rigid fixation devices such as the Ransford Loop, Hartshill rectangles, cerclage wiring or other legally marketed cervical spine stabilization device.

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

### Substantial Equivalence: e.

The OSStaple™ Staple System is substantially equivalent to the Medicrea C-JAWS Cervical Compressive Mini Frame (K062181) and the Depuy BOWTI™ Anterior Buttress Staple (K021039)

The FDA has classified these equivalent devices as Class II devices (e.g. 21 CFR, 888.3060). The OSStapleTM Staple System is a Class II medical device.

The OSSforce™ Controller heating unit was approved via 510(k) K023203 for orthopedic use, K023486 for maxillofacial use, K023488 for craniofacial use and no modifications are required for the additional indications. The OSSforce™ Controller uses the joule (heating) effect of electrical current in a conductor to increase the temperature of the Nitinol staple (as the conductor) allowing it to return to its stable austenitic phase position thereby causing compression. Circuitry controls the heating effect and prevents tissue damage by limiting current and time.

---

(Signature)

W. Casey Fox, Ph.D. P.E. CEO BioMedical Enterprises, Inc.

a marka ministra minta katika katika ke katika mengela mengan mengan mengan mengan mengan mengan mengan mengan mengan mengan mengan mengan mengan mengan mengan mengan mengan

5/29/07
(Date)

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

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three overlapping, curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.

MAY 3 0 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomedical Enterprises, Inc. % W. Casey Fox, Ph.D., P.E. President 14785 Omicron Drive, Suite 205 San Antonio, Texas 78245

Re: K061385

Trade Name: OSStaple™ System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: May 17, 2007 Received: May 21, 2007

Dear Dr. Fox:

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.

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

Page 2 - W. Casey Fox, Ph.D., P.E.

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 toll-free number [phone] or [phone] or at Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

APPENDIX II (Indication for Use)

Device Name: OSStaple™ Staple System

Additional indications for the OSStaple™ are:

For use in conjunction with traditional rigid fixation in cervical fusion procedures as a means to maintain the relative position of bony tissue such as allografts. This device is for use with traditional rigid fixation devices such as the Ransford Loop, Hartshill rectangles, cerclage wiring or other legally marketed cervical spine stabilization device. This device is not intended to be used alone for load bearing applications.

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-1. Restorative, Division of Gen and Neurologics rmat 1-2-96) 510(k) I