OMNITECH SYSTEM & EASY LOCK OSTEOSYSTEM WITH XTREMITIES PLATES

K050681 · TriMed, Inc. · HRS · Jul 27, 2005 · Orthopedic

Device Facts

• Record ID: K050681
• Device Name: OMNITECH SYSTEM & EASY LOCK OSTEOSYSTEM WITH XTREMITIES PLATES
• Applicant: TriMed, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Jul 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Omnitech System: The Omnitech Small Fragment Osteosynthesis System is intended for use in the internal fixation of small bones in the hand and foot. EasyLock Osteosystem & Xtremities: The Easy Lock and Xtremities implants may be used for permanent or temporary osteosynthesis of small bones, tarsal and carpal fractures, and for the fixation of osteotomies or arthrodesis.

Device Story

Omnitech and Easy Lock Osteosystem are metallic bone fixation implants (plates and screws) used for internal fixation of small bones in hand and foot. Devices provide mechanical stabilization for fractures, osteotomies, or arthrodesis. Operated by orthopedic surgeons in clinical/surgical settings. Implants are surgically implanted to maintain bone alignment during healing process; provide structural support to facilitate bone union. Benefit includes stabilization of small bone segments to promote healing and restore function.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Metallic bone fixation appliances (plates and screws). Design and materials are consistent with existing orthopedic fixation standards for small bone applications.

Indications for Use

Indicated for patients requiring internal fixation of small bones in the hand and foot, including tarsal and carpal fractures, osteotomies, or arthrodesis. Suitable for permanent or temporary osteosynthesis.

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

• Lepine EIS Threaded Screws for Metatarsal Fixation (K991964)
• Zimmer Herbert Bone Screw (K792022)
• Newdeal Hallu Plates (K021626)
• Synthes Modular Foot System (K001941)
• Howmedica Profyle Hand & Small Fragment System (K961941)
• KMI Wrist Fusion System (K991873)
• Acumed Wrist Fusion Plate (K021321)

Submission Summary (Full Text)

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K050681

## 510(K) Summary of Safety and Effectiveness OMNITECH and EASY LOCK OSTEOSYSTEM

| Submitted By: | TriMed, Inc.<br>25768 Parada Drive<br>Valencia, CA 91355<br>[phone] |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Registration #: | 2031009 |
| Manufactured By: | Biotech International<br>305, Allées de Craponne<br>13300 Salon de Provence, France<br>Phone: [phone]<br>Fax: [phone] |
| Manufacturer's Registration #: | K050681 |
| Prepared By/Contact Person: | Kelli Anderson<br>Phone: [phone]<br>Fax: [phone] |
| Proprietary Name: | Omnitech<br>Easy Lock Osteosystem with<br>Xtremities Plates |
| Classification: | Class II: Plate Fixation Bone<br>Section 888.3030<br>Screw Fixation Bone<br>Section 888.3040 |
| Classification Code: | HRS<br>HWC |
| Summary Preparation Date: | June 3, 2005 |

## Intended Use:

Omnitech System:

The Omnitech Small Fragment Osteosynthesis System is intended for use in the internal fixation of small bones in the hand and foot.

EasyLock Osteosystem & Xtremities:

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K050681

The Easy Lock and Xtremities implants may be used for permanent or temporary osteosynthesis of small bones, tarsal and carpal fractures, and for the fixation of osteotomies or arthrodesis.

## Substantial Equivalence:

Omnitech

K991964 - Lepine EIS Threaded Screws for Metatarsal Fixation K792022 - Zimmer Herbert Bone Screw K021626 - Newdeal Hallu Plates K001941 - Synthes Modular Foot System K961941 - Howmedica Profyle Hand & Small Fragment System

Easy Lock

K021626 - Newdeal Hallu Plates K961941 - Howmedica Profyle Hand & Small Fragment System (Now Stryker Leibinger) K991873 – KMI Wrist Fusion System K021321 - Acumed Wrist Fusion Plate

Luci Anderson

Kelli Anderson Regulatory Affairs Specialist

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine and health.

JUL 8 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kelli Anderson Regulatory Affairs Specialist TriMed, Inc. 25768 Parada Drive Valencia, California 91355

Re: K050681

Trade/Device Name: Omnitech® System EasyLock Osteosystem & Xtremities Regulation Number: 21 CFR 888.3030, 21 CFR 888.3040 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories, Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HRS, HWC Dated: June 7, 2005 Received: June 9, 2005

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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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/dsma/dsmamain.html

Sincerely yours,

Hypt Rhodes

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): K050681

Omnitech® System Device Name: EasyLock Osteosystem & Xtremities

Indications For Use

Omnitech System:

The Omnitech Small Fragment Osteosynthesis System is intended for use in the internal fixation of small bones in the hand and foot.

EasyLock Osteosystem & Xtremities:

The Easy Lock and Xtremities implants may be used for permanent or temporary osteosynthesis of small bones, tarsal and carpal fractures, and for the fixation of osteotomies or arthrodesis.

Prescription Use 7 (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)

Hyt Durdis

Division of General, Restorative, and Neurological Devices

510(k) Number K050681

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