OMEGA II SYSTEM

K020772 · Howmedica Osteonics Corp. · KTT · Jun 5, 2002 · Orthopedic

Device Facts

• Record ID: K020772
• Device Name: OMEGA II SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: KTT · Orthopedic
• Decision Date: Jun 5, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Omega® II System is intended for use in the temporary stabilization of fractures of the proximal femur.

Device Story

Omega® II System is a metallic bone fixation system for proximal femur fracture stabilization. Components include hip plates, lag screws, and compression screws. Device is a modification of the Omega + Plus System, featuring a lower profile hip plate. Used by orthopedic surgeons in clinical settings to provide temporary mechanical fixation of bone fragments. Output is the physical stabilization of the fracture site, facilitating healing. Benefit is the restoration of structural integrity to the proximal femur following trauma.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metallic bone fixation appliance. Components: hip plates, lag screws, compression screws. Design: low-profile hip plate. Materials: metallic (specific alloys not disclosed). Sterilization: not specified. Connectivity: none (mechanical device).

Indications for Use

Indicated for temporary stabilization of proximal femur fractures, including intracapsular femoral neck fractures and intertrochanteric fractures.

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

Reference Devices

• Synthes DHS Side Plate

Submission Summary (Full Text)

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# JUN 0 5 2002

510(k) PremarketNotification

## 510(k) Summary for the Omega® II System

Proprietary Name: Common Name: Classification Name and Reference

Regulatory Class: Device Product Code: For Information contact: Omega® II System Compression Hip Screw System Single/multiple component metallic bone fixation appliances and accessories 21 CFR 8888.3030 Class II 87 KTT Karen Ariemma, Regulatory Affairs Specialist Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401-1677 Phone: [phone] Fax: [phone] March 6, 2002

Date Summary Prepared:

### Description:

The Omega® II System is a compression hip screw system designed to treat various indications in the proximal femur. The Omega® II System consists of a range of Hip Plates, Lag Screws and a Compression Screw as well as the corresponding instruments. The Omega® II System is a modification to the existing Omega + Plus System. The subject Omega® II Low Profile Hip Plate is shorter and has a thinner profile than the predicate Omega + Plus Side Plate. The profile of the Omega® III Low Profile Hip Plate is similar to the design of the Synthes DHS Side Plate. The Omega® II Low Profile Hip Plates use the same Lag Screws as the predicate Omega® + Plus System.

# Intended Use:

The Omega® II System is intended for use in the temporary stabilization of fractures of the proximal femur.

### Substantial Equivalence:

The design and function of the Omega® II System is substantially equivalent to that of the predicate devices. Both the subject and predicate systems offer Hip Plates in varying lengths and angles, and offer a combination of Lag Screws, Compression Screws and Locking Screws.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design of three human profiles facing to the right, arranged in a way that suggests forward movement or progress.

JUN 0 5 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Elizabeth Staub Vice President. Ouality Assurance/Regulatory Affairs/Clinical Research Howmedica Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677

Re: K020772 Trade Name: Omega® II System Regulatory Number: 21 CFR 888.3030 Regulatory Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: March 6, 2002 Received: March 8, 2002

Dear Ms. Staub:

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. Elizabeth Staub

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Sincerely yours,

Marle N Milburn

Celia 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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510(k) Number (if known): K OD 0772

Device Name: Omega® II System

Indications for Use

The Omega® II System is indicated for temporary stabilization of fractures of the proximal femur which may include the following:

- Intracapsular fractures of the femoral neck .
- Intertrochanteric fractures .

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Mark n Wilkerson

ivision of General, Restorative and Neurological Devices

510(k) Number _