OMEGA 3 TROCHANTERIC STABILIZING PLATE

K081278 · Howmedica Osteonics Corp. · KTT · May 29, 2008 · Orthopedic

Device Facts

• Record ID: K081278
• Device Name: OMEGA 3 TROCHANTERIC STABILIZING PLATE
• Applicant: Howmedica Osteonics Corp.
• Product Code: KTT · Orthopedic
• Decision Date: May 29, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

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

Device Story

Omega™ 3 Trochanteric Stabilizing Plate is a metallic compression screw system for proximal and distal femoral fracture fixation. Device provides temporary stabilization of bone segments to facilitate healing. Used by orthopedic surgeons in clinical/surgical settings. System components are available sterile or non-sterile. Output is physical stabilization of bone fractures. Benefits include restoration of structural integrity for patients with femoral fractures, deformities, or requiring arthrodesis.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Metallic bone fixation appliance; compression screw system. Design and materials are consistent with the predicate Omega™ 3 System. Mechanical properties verified via bench testing.

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.

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™ 3 System (K081278)

Submission Summary (Full Text)

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K081278 (pg 192)

MAY 29 2008

## Omega™ 3 Trochanteric Stabilizing Plate Proprietary Name: Compression Screw System Common Name: Single/multiple component metallic bone Classification Name and fixation appliances and accessories, 21 CFR Reference: 888.3030 87 KTT Device Product Code: Andrea Dwyer, Regulatory Affairs Associate For Information Contact: Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: [phone] Fax: [phone] May 5, 2008 Date Summary Prepared:

## Summary of Safety and Effectiveness Omega™ 3 Trochanteric Stabilizng Plate

#### Description:

The Omega™ 3 Trochanteric Stabilizing Plate is a compression screw system designed to treat various types of fractures of the proximal 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:

- Intracapsular and basal neck fractures including transcervical and subcapital fractures .
- Intertrochanteric fractures .

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K081278(pg2g2)

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

# Substantial Equivalence:

The subject Omega™ 3 Trochanteric Stabilizing Plate shares the same intended use, and basic design concepts as that of the currently available Omega™ 3 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 seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 2 9 2008

Howmedica Osteonics Corp. % Ms. Andrea Dwyer Regulatory Affairs Associate 325 Corporate Drive Mahwah, New Jersey 07430

> K081278 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: May 5, 2008 Received: May 6, 2008

Dear Ms. Dwyer:

Re:

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. Andrea Dwyer

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N Millican

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

Enclosure

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510(k) Number (if known):

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:

- . 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 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) | Neil R. Ogden for MAM |
|--------------------------------------------------------|-----------------------|
| (Division Sign-Off) | |
| Division of General, Restorative, | |
| and Neurological Devices | |
| 510(k) Number | K081278 |

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