Osteonics Extended Femoral Bearing Head

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K982936 ↗

FDA Product Code

LWJ

Device Class

Class II

Regulation

21 CFR Part 888.3360

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 Osteonics Extended Femoral Bearing Head used for?

  This device is designed specifically for hip arthroplasty (total hip replacement surgery). Its extended neck offsets (+12.5mm and +15mm) help restore ligamentous balance, improving joint stability and alignment during articulation. The modular spherical bearing head ensures compatibility with various femoral stem configurations, making it suitable for patients requiring customised hip replacements.

• How is the Osteonics Extended Femoral Bearing Head supplied, and is it reusable?

  The device is supplied sterile and intended for single-use only. This ensures patient safety by preventing cross-contamination and maintains the device’s performance standards. Single-use also aligns with clinical best practices for orthopedic implants to minimise infection risks.

• What sizes and configurations are available for this femoral bearing head?

  The device comes in four diameters: 22mm, 26mm, 28mm, and 32mm. It interfaces mechanically with compatible Osteonics femoral stems using either Morse or C-Taper configurations, allowing for flexibility in surgical planning based on patient anatomy and clinical needs.

• Can this device be used in MRI environments?

  Yes, the Osteonics Extended Femoral Bearing Head is designed to be MRI-compatible. This means it can be safely used in patients who may require MRI imaging post-surgery, provided the device’s specifications and manufacturer guidelines are followed. Always verify compatibility with your MRI facility’s protocols.

• How should the device be stored before use?

  The device should be stored in its original sterile packaging until ready for use. Ensure the packaging remains unopened and undamaged to preserve sterility. Store in a clean, dry environment away from direct sunlight or extreme temperatures, as per standard orthopedic implant handling procedures.