TRIMED OSTEOTOMY PLATE

K043263 · TriMed, Inc. · HRS · Jan 14, 2005 · Orthopedic

Device Facts

• Record ID: K043263
• Device Name: TRIMED OSTEOTOMY PLATE
• Applicant: TriMed, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Jan 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TriMed Unlar Osteotomy Plate is intended for use in osteotomy procedures of the ulna.

Device Story

TriMed Ulnar Osteotomy Plate is a metallic bone fixation device used in surgical osteotomy procedures of the ulna. The plate provides stabilization to the bone during the healing process following an osteotomy. It is intended for use by surgeons in an operating room setting. The device functions as a mechanical implant to maintain alignment and fixation of the ulna bone segments.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metallic bone fixation plate. Class II device under 21 CFR 888.3030. Product code HRS.

Indications for Use

Indicated for patients undergoing osteotomy procedures of the ulna.

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

• Rayhack Osteotomy System (K952766)
• Synthes 3.5/4.5 mm. LCP Metaphyseal Plates (K030310)

Submission Summary (Full Text)

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JAN 1 4 2005

K043263

## 510(K) Summary of Safety and Effectivenss TRIMED, INC. ULNAR OSTEOTOMY PLATE

| Submitted By: | TriMed, Inc.<br>25768 Parada Drive<br>Valencia, CA 91355<br>[phone] |
|-----------------------------|---------------------------------------------------------------------------|
| Registration #: | 2031009 |
| Prepared By/Contact Person: | Kelli Anderson<br>Phone: [phone]<br>Fax: [phone] |
| Proprietary Name: | TriMed Ulnar Osteotomy Plate |
| Classification: | Class II: Bone Fixation Plates<br>Section 888.3030 |
| Classification Code: | HRS |
| Summary Preparation Date: | November 22, 2004 |

Intended Use:

The TriMed Unlar Osteotomy Plate is intended for use in osteotomy procedures of the ulna.

Substantial Equivalence:

K952766 Rayhack Osteotomy System K030310 Synthes 3.5/4.5 mm. LCP Metaphyseal Plates

Lilli Anderson

Kelli Anderson Regulatory Affairs Specialist

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 4 2005

TriMed, Inc. C/o Kelli Anderson Regulatory Affairs Specialist 25768 Parada Drive Valencia, California 91355

Re: K043263

Trade Name: TriMed Ulnar Osteotomy Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: November 22, 2004 Received: November 24, 2004

Dear Ms. Anderson:

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. Kelli Anderson

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 vours,

Mark A. Milkenon

Celia M. Witten, Ph.D., M.D. 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): K043263

Device Name: TriMed Ulnar Osteotomy Plate

Indications For Use: The TriMed Ulnar Osteotomy Plate is intended for use in osteotomy procedures of the ulna.

Prescription Use (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)

Mark Nelsen

Division of General, Restorative, and Neurological Devices

043263

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