TRIMED BONE PLATES

K060041 · TriMed, Inc. · HRS · Feb 7, 2006 · Orthopedic

Device Facts

• Record ID: K060041
• Device Name: TRIMED BONE PLATES
• Applicant: TriMed, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Feb 7, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TriMed Bone Plates are intended for use in the fixation of fractures to the Tibia, Fibula, Ulna, Radius and the Humerus.

Device Story

TriMed Bone Plates system consists of stainless steel plates, screws, and surgical accessories. Used by surgeons for internal fixation of small and long bone fractures in the tibia, fibula, ulna, radius, and humerus. Device provides mechanical stabilization of bone fragments to facilitate healing. Operates as a traditional orthopedic fixation system; no electronic or software components.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material characteristics.

Technological Characteristics

Materials: Stainless steel. Principle: Mechanical bone fixation via plates and screws. Form factor: System of plates, screws, and surgical accessories. Energy source: None (mechanical).

Indications for Use

Indicated for fixation of fractures of the tibia, fibula, ulna, radius, and humerus.

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

• Acumed Congruent Bone Plate System (K013655)
• Smith & Nephew PERI-LOC (K051735)

Submission Summary (Full Text)

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FEB 7 2006

K 06004/

## 510(K) Summary of Safety and Effectivenss TRIMED, INC. BONE PLATES

| 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 Bone Plates |
| Classification: | Class II: Bone Fixation Plates<br>HRS - Section 888.3030<br>Class II: Bone Fixation Screws<br>HWC - Section 888.3040 |
| Summary Preparation Date: | January 3, 2006 |

#### I. Indications for Use:

The TriMed Bone Plates are intended for use in the fixation of fractures to the Tibia, Fibula, Ulna, Radius and the Humerus.

### II. Device Description:

TriMed Bone Plates is a system of plates, screws and surgical accessories used in the fixation of small and long bone fractures. The plates and screws are all made of stainless steel.

#### III. Substantial Equivalence:

K013655 Acumed Congruent Bone Plate System K051735 Smith & Nephew PERI-LOC

Kein Anderson

Regulatory Affairs Specialist

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Public Health Service

FEB 7 2006 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kelli Anderson Regulatory Affairs Specialist Trimed, Inc. 25864 Tournament Rd. Suite A. Valencia, California 91355

Re: K060041 Trade/Device Name: TriMed Bone Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: January 3, 2006 Received: January 6, 2006

Dear Mr. Anderson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed 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 eonimer of 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 I ou mayy arere, which 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

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### Page 2 - Mr. Anderson

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. 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" (21 CFR 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,

2

Mark N. Melkerson, Acting 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): K060041

Device Name: TriMed Bone Plates

Indications For Use:

.

The TriMed Bone Plates are intended for use in the fixation of fractures to the Tibia. Fibula, Ulna, Radius and the Humerus.

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)

060

(Division Sign-Off) (Division Sign-Off)
Division of General, Restorative,
Division of General, Devices Division of General,
and Neurological Devices
and Neurological Devices

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