OMEGA 3 SYSTEM

K062066 · Howmedica Osteonics Corp. · KTT · Aug 15, 2006 · Orthopedic

Device Facts

• Record ID: K062066
• Device Name: OMEGA 3 SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: KTT · Orthopedic
• Decision Date: Aug 15, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The subject and predicate devices are available sterile and non-sterile intended for use in the temporary stabilization of fractures of the proximal and distal femur.

Device Story

Omega™ 3 System is a metallic compression screw system for temporary stabilization of proximal and distal femoral fractures. Used by orthopedic surgeons in clinical/surgical settings to provide bone fixation. Device components are implanted to stabilize fractures or support osteotomies/arthrodesis. Mechanical properties are comparable to predicate systems, facilitating bone healing through rigid fixation.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Metallic bone fixation appliance; compression screw system. Design and materials are consistent with predicate systems (Omega™ Plus/Omega™ 2).

Indications for Use

Indicated for temporary stabilization of proximal and distal femoral fractures in patients requiring fixation, including intracapsular, basal neck (transcervical, subcapital), intertrochanteric, subtrochanteric, supracondylar, and intracondylar fractures, as well as hip osteotomies and hip arthrodesis.

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™ Plus System
• Omega™ 2 System

Submission Summary (Full Text)

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K062066 (pg 1 of 2)

### Summary of Safety and Effectiveness Omega™ 3 System

| Proprietary Name: | Omega™ 3 System |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Compression Screw System |
| Classification Name and Reference | Single/multiple component metallic bone<br>fixation appliances and accessories, 21 CFR<br>§888.3030 |
| Device Product Code: | 87 KTT |
| For Information Contact: | Francisco Haro, Regulatory Affairs Specialist<br>Howmedica Osteonics Corp.<br>325 Corporate Drive<br>Mahwah, NJ 07430<br>Phone: [phone]<br>Fax: [phone] |
| Date Summary Prepared: | July 19, 2006 |

#### Description:

The Omega™ 3 System is a compression screw system designed to treat various types of fractures of the proximal and distal femur.

#### Intended Use:

The modifications do not alter the intended use of the predicate system as cleared in the referenced premarket notifications. The subject and predicate devices are available sterile and non-sterile intended for use in the temporary stabilization of fractures of the proximal and distal femur. The indications for use for the Omega™ 3 System are provided below.

#### Indications for Use:

The Omega™ Plus, Omega™ 2, and Omega™ 3 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 .

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K062066 (pg 2 of 2)

- Intertrochanteric fractures .
- Subtrochanteric fractures .
- . Supracondylar fractures
- . Intracondylar fractures
- Osteotomies for patients with diseases or deformities of the hip .
- . Hip arthrodesis

## Substantial Equivalence:

The subject Omega™ 3 System shares the same intended use, and basic design concepts as that of the currently available Omega™ Plus System and Omega™ 2 System. Mechanical testing demonstrated comparable mechanical properties to the predicate components and is substantially equivalent to these devices.

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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 stylized caduceus symbol, which features a staff with a snake winding around it, overlaid on three human figures. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 5 2006

Howmedica Osteonics Corporation % Mr. Francisco Haro Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

Re: K062066

Trade/Device Name: Omega™ 3 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: July 19, 2006 Received: July 21, 2006

Dear Mr. Haro:

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

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Page 2 - Mr. Francisco Haro

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 100-100. 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" (210) Part 807.97). You may ottain 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,

Barbave Onelino
to

Mark N. Melkers Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# KOG2

510(k) Number (if known):

Device Name: Omega™ 3 System

Indications for Use:

The Omega™ Plus, Omega™ 2, and Omega™ 3 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 | X |
|-----------------------------|---|
| (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 OF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE) for MACU

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

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| K Number | K162066 |
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