OSSTAPLE

K023203 · Biomedical Ent., Inc. · JDR · Oct 17, 2002 · Orthopedic

Device Facts

• Record ID: K023203
• Device Name: OSSTAPLE
• Applicant: Biomedical Ent., Inc.
• Product Code: JDR · Orthopedic
• Decision Date: Oct 17, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BioWarm" is indicated for use as an ancillary device for the OSStaple" staple system.

Device Story

BioWarm is a heating unit modification for the OSStaple bone staple system; designed to heat shape-memory Nitinol staples to achieve bone compression. Device consists of a console with user-adjustable current and time controls; electrode handle with activation button. Operator (clinician) sets parameters based on staple size/configuration. System provides visual/audible feedback for current delivery and contact status; automatic current cessation upon cycle completion. Used in clinical settings to facilitate bone fixation; ensures proper staple deployment via controlled thermal activation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Console-based heating unit for Nitinol staples. Features user-adjustable current and time controls, electrode handle with activation switch, and visual/audible indicators for contact and current flow. Operates via electrical current delivery to heat staples. Software-controlled circuitry manages automatic current cessation.

Indications for Use

Indicated for use as an ancillary device for the OSStaple staple system, which is used for hand and foot bone fragment and osteotomy fixation, joint arthrodesis, proximal tibial metaphysic osteotomy fixation, and soft tissue to bone fixation (e.g., anterior cruciate reconstruction).

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Warmsystem (K993714)
• Warmsystem (K001219)
• Warmsystem (K001353)
• Warmsystem (K001354)

Submission Summary (Full Text)

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K04303 page 142

## APPENDIX IV (510(k) Summary)

OCT 1 7 2002

**Product:** BioWarm
(Osstaple™ staple system)

BioMedical Enterprises, Inc. (BME) intends to introduce a device modification to the original approved Warmsystem to heat shape memory Nitinol staples (the "OSStaple™") to achieve compression.

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

Date Prepared: September 25, 2002

- b. Classification name: Staple, Fixation, Bone Common/Usual Name: Bone staple Proprietary Name: OSStaple™, BioWarm
- Intended Use: C.

The BioWarm" is indicated for use as an ancillary device for the OSStaple" staple system.

## d. Device Description

The BioWarm™ represents a modification to the Warmsystem currently in use with the OSStaple" bone staple system. The BioWarm has an on/off switch and two user adjusted controls. A user adjusted current and user adjusted time controls are on the front of the console. The controls are set to the requirements of a specific staple size and configuration. The BioWarm" gives both visual and audible indications of current delivery and an audible signal upon automatic completion of current delivery. The BioWarm", on the electrode handle, also provides visual indication of positive contact between the electrode and staple to be heated and visual indication of actual current flow. Current is activated with a button switch on the handle of the BioWarm electrode and will cease if the button is released prior to the automatic cessation by the circuitry

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## Substantial Equivalence: e.

The Warmsystem heating unit was approved via 510(k)s K993714, 001219, 001353 and 001354 and no fundamental technology changes are represented with the BioWarm™ modification.

(Signature)

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

9/24/02
(Date)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K023203

Trade/Device Name: OSStaple™ Staple System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: JDR Dated: September 24, 2002 Received: September 25, 2002

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. Iisting 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 – Dr. W. Casey Fox

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 yours,

Mark N. Millman

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KOL 3>03

## APPENDIX III (Indication For Use)

Device Name: Memograph® Staple System

Indications for use: The Memograph® Staple is intended for:

1) hand and foot bone fragment and osteotomy fixation and joint arthrodesis, 2) fixation of proximal tibial metaphysic osteotomy, and 3) fixation of soft tissue to bone such as anterior cruciate reconstruction.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Pcr 21 CFR 801.109) OR

Over-The-Counter Use

Mark A. Millan
(Optional Format 1-2-96)
(Division Sign-Off)

sion of General, Restorative and Neurological Devices

510(k) Number _K033203