OMEGA 2 SYSTEM

K041001 · Howmedica Osteonics Corp. · KTT · Jul 1, 2004 · Orthopedic

Device Facts

• Record ID: K041001
• Device Name: OMEGA 2 SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: KTT · Orthopedic
• Decision Date: Jul 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Omega™ Plus and 2 Systems are intended for use in the temporary stabilization of fractures of the proximal and distal femur.

Device Story

Omega™ 2 System is a metallic bone fixation system consisting of compression screws and plates. Used for temporary stabilization of proximal and distal femoral fractures; hip osteotomies; hip arthrodesis. System components are implanted by surgeons in a clinical/OR setting to provide mechanical fixation of bone segments. Device functions by providing structural support to stabilize fractures during healing. Output is the physical stabilization of the bone. Benefits include restoration of alignment and support for bone union.

Clinical Evidence

Bench testing only; no clinical data provided. Mechanical testing demonstrated comparable mechanical properties to predicate components.

Technological Characteristics

Metallic bone fixation system; components include compression screws and plates of varying lengths and angles. Materials are consistent with existing predicate systems. No software or electronic components.

Indications for Use

Indicated for temporary stabilization and fixation of proximal and distal femoral fractures, including intracapsular, basal neck (transcervical, subcapital), intertrochanteric, subtrochanteric, supracondylar, and intracondylar fractures. Also indicated for hip osteotomies and hip arthrodesis in patients with hip diseases or deformities.

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

• Omega™ II
• Omega™ Plus
• Omega™ Systems

Submission Summary (Full Text)

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# JUL 0 1 2004

K041001
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### 510(k) Summary of Safety and Effectiveness for the Omega™ 2 System

| Proprietary Name: | Omega™ 2 System |
|-----------------------------------|----------------------------------------------------------------------------------------------------|
| Common Name: | Compression Screw System |
| Classification Name and Reference | Single/multiple component metallic bone fixation<br>appliances and accessories<br>21 CFR §888.3030 |
| Regulatory Class: | Class II |
| Device Product Code: | 87 KTT |
| For Information contact: | Vivian Kelly, Regulatory Affairs Specialist |
| | Howmedica Osteonics Corp. |
| | 325 Corporate Drive |
| | Mahwah, NJ 07430 |
| | Phone: [phone] |
| | Fax: [phone] |
| Date Summary Prepared: | April 16, 2004 |

#### Description:

The Omega™ 2 System is a compression screw system designed to treat various types of fractures of the proximal and distal femur. The Omega™ 2 System is a modification to the existing Omega™ II, Omega™ Plus and Omega™ Systems. The subject Omega™ 2 System is a line extension to the predicate devices to modify and add new components to the system.

#### Intended Use:

The Omega™ Plus and 2 Systems are intended for use in the temporary stabilization of fractures of the proximal and distal femur.

#### Substantial Equivalence:

The design and function of the Omega™ 2 System is substantially equivalent to that of the predicate devices. Both the subject and predicate systems offer different types of plates in varying lengths and angles for use with the other accessories in the system. This system is equivalent to other systems on the market in regards to design, materials, indications and operational principals. Mechanical testing demonstrated comparable mechanical properties to the predicate components.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three stripes on its wing, symbolizing service, science, and security. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

JUL 01 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vivian Kelly Regulatory Affairs Specialist Howmedica Osteonics Corporation 325 Corporate Drive Mahwah, New Jersey 07430

Re: K041001 Trade/Device Name: Omega™ 2 System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: April 16, 2004 Received: April 19, 2004

Dear Ms Kelly:

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 - Vivian Kelly

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,

Muriam C. Provost

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): KO41001 Device Name: Omega™ 2 System

Indications for Use:

The Omega™ Plus and 2 Systems are intended for use in the temporary stabilization of types of fractures of the proximal and distal femur. The subject devices are indicated for fixation of proximal and distal femoral fractures including but not limited to:

- Intracapsular and basal neck fractures including transcervical and subcapital fractures .
- Intertrochanteric fractures .
- . Subtrochanteric fractures
- Supracondylar fractures .
- Intracondylar fractures .
- Osteotomies for patients with diseases or deformities of the hip .
- Hip arthrodesis ◆

Prescription Use Over-The-Counter Use _ AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

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

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