Omnifit AD-HA Hip Stem Series

• • Terminated Z-0902-2009 FDA Unclassified (pre-2012) ·initiated 13 Nov 2008

  Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices.

Full name

Osteonics Omnifit Ad-Ha Hip Stem Series

510(k) Number

K941366 ↗

FDA Product Code

MEH

Device Class

Class II

Regulation

21 CFR Part 888.3353

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Osteonics(R) Omnifit(R) Normalized Hip Stem

  Class II

  FDA 510(k) K932519 Active Cleared 10 Mar 1994

• Omnifit II Hip Prostheses: Cement Fixation

  Class II

  FDA 510(k) K870235 Active Cleared 29 May 1987

• Osteonics Total Elbow System Open recall

  Class II

  FDA 510(k) K980502 Active Cleared 5 May 1998

• MC2P Acetabular Component Open recall

  Class II

  FDA 510(k) K900438 Active Cleared 18 Apr 1990

• Shoulder Microstructured Humeral Prosthesis

  Class II

  FDA 510(k) K883816 Active Cleared 10 Nov 1988

• Osteonics(R) Mpss Hip Stem Series

  Class II

  FDA 510(k) K905275 Active Cleared 28 Jan 1991

See all devices from Osteonics Corp. →

• What is the Omnifit AD-HA Hip Stem Series used for?

  The Omnifit AD-HA Hip Stem Series is designed specifically for total hip arthroplasty (replacement surgery). Its modular, press-fit stem with hydroxyapatite coating enhances primary stability and promotes bone growth, reducing the risk of loosening over time. The coating encourages osseointegration—direct bonding between bone and the implant—while the modular design allows customization to fit diverse femoral anatomies and surgical approaches.

• How is the Omnifit AD-HA Hip Stem Series supplied and prepared for use?

  The device is supplied as a sterile, single-use implant, ensuring compliance with medical device sterility standards. It must be handled using sterile techniques to maintain its integrity before surgical use. The modular components are pre-packaged to prevent contamination, and the manufacturer’s storage guidelines (e.g., protected from moisture/damage) must be followed until implantation.

• Is the hydroxyapatite coating on this stem reusable, or is it intended for single-use?

  The Omnifit AD-HA Hip Stem Series is explicitly designed for single-use only. Hydroxyapatite coatings, while biocompatible, are not intended for repeated surgical applications due to potential degradation, contamination risks, or loss of coating integrity. Single-use ensures patient safety and maintains the coating’s effectiveness in promoting osseointegration.

• What sizes and configurations are available for this hip stem?

  The series includes multiple stem designs and sizes tailored to accommodate different femoral anatomies and surgical approaches. Exact dimensions and configurations are detailed in the manufacturer’s surgical technique guide, which provides compatibility charts for proximal femur shapes, neck-shaft angles, and offset requirements. Consult the packaging or technical documentation for the specific models available in your region.

• How should the Omnifit AD-HA Hip Stem Series be stored before use?

  Storage must adhere to sterile medical device protocols to preserve the implant’s integrity. The device should be kept in its original, unopened packaging in a clean, dry environment protected from direct sunlight, extreme temperatures, or physical damage. Avoid exposure to chemicals or contaminants, and follow the manufacturer’s expiration date to ensure sterility and performance. Refrigeration is not required unless specified in the packaging instructions.