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 Description

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

AI/ML Overview

The Omega™ 3 Trochanteric Stabilizing Plate is a compression screw system designed to treat various types of fractures of the proximal femur. The study conducted to demonstrate its safety and effectiveness was a mechanical testing study comparing the new device to existing predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Comparable mechanical properties to predicate devices	Mechanical testing demonstrated comparable mechanical properties to the predicate components.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the specific numerical sample size used for the mechanical testing, nor does it detail the provenance of the data (e.g., country of origin, retrospective or prospective). It simply states "Mechanical testing."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not applicable. The basis for substantial equivalence was mechanical testing, not expert-adjudicated clinical or image data.

4. Adjudication Method for the Test Set:

This information is not applicable. The study involved mechanical testing, not human adjudication of a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The study was focused on the mechanical properties of the device itself, not on human reader performance with or without AI assistance.

6. Standalone Performance Study:

A standalone performance study was conducted in the form of mechanical testing of the device. This testing assessed the device's inherent mechanical properties without human intervention or interpretation as part of the primary outcome.

7. Type of Ground Truth Used:

The "ground truth" for this study was the established mechanical properties and performance of legally marketed predicate devices. The new Omega™ 3 Trochanteric Stabilizing Plate was compared to these existing devices.

8. Sample Size for the Training Set:

This information is not applicable. The study involved mechanical testing of a medical device, not a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as there was no training set for a machine learning algorithm. The ground truth for the comparison was based on the established mechanical performance of predicate devices.

Summary

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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: (201) 831-6250 Fax: (201) 831-6038 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:

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 (240) 276-0120. 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 (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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):

Device Name: Omega™ 3 System

Indications for Use:

. 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

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
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.(b)
Classification. Class II.