BIOPRO MEMORY STAPLE

K061798 · Biopro, Inc. · JDR · Aug 21, 2006 · Orthopedic

Device Facts

• Record ID: K061798
• Device Name: BIOPRO MEMORY STAPLE
• Applicant: Biopro, Inc.
• Product Code: JDR · Orthopedic
• Decision Date: Aug 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1. Hand and foot bone fragment and osteotomy fixation and joint arthrodesis of the hand and foot bones. 2. Fixation of soft tissue to bone such as anterior cruciate reconstruction

Device Story

Biopro Memory Staple is a metallic bone fixation device used for stabilizing bone fragments, osteotomies, and arthrodesis in the hand and foot, as well as attaching soft tissue to bone. The device is implanted by a surgeon in a clinical or surgical setting. It functions as a mechanical fixation appliance to maintain bone alignment and support healing. The device provides structural stability to the surgical site, facilitating bone fusion or soft tissue attachment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metallic bone fixation appliance; Class II; Product Code JDR; 21 CFR 888.3030.

Indications for Use

Indicated for hand and foot bone fragment fixation, osteotomy fixation, joint arthrodesis of hand and foot bones, 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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 2 1 2006

BioPro % Mr. David Mrak Director of Product Development 17 Seventeenth Street Port Huron, Michigan 48060

Re: K061798

Trade/Device Name: Biopro Memory Staple 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: June 21, 2006 Received: June 26, 2006

Dear Mr. Mrak:

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 - Mr. David Mrak ﮨﮯ ﮨﯿ

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,

Saibare Buekus

Mark N. Melkerson 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):

Device Name: Biopro Memory Staple

Indications For Use:

1. Hand and foot bone fragment and osteotomy fixation and joint arthrodesis of the hand and foot bones.

2. Fixation of soft tissue to bone such as anterior cruciate reconstruction

Prescription Use xxxxx (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aubene Strickland Johnson

(Division Sign-Off) (Wivision big-----------------------------------------------------------------------------------------------------------------------------------------------------------------Division of the Provices

510(k) Number K061798

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