Osteonics Omnifit-C Cemented Hip Stem (Line Extension)

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

510(k) Number

K972460 ↗

FDA Product Code

JDI

Device Class

Class II

Regulation

21 CFR Part 888.3350

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 Omnifit-C Cemented Hip Stem used for?

  This prosthesis is intended for patients requiring hemi-hip replacement, bipolar hip replacement, or total hip replacement. It is designed to be cemented in place to restore joint function.

• How is the Omnifit-C Hip Stem supplied?

  The device is supplied for single-use only. It is a Class II prosthesis manufactured by Osteonics Corp. and is intended for orthopedic surgical applications.

• What distinguishes this model from the standard Omnifit-C?

  This line extension features a modified design with a 5mm longer neck compared to the predicate Osteonics Omnifit-C Cemented Hip Stem. This change may address specific anatomical or biomechanical requirements.

• Is this device reusable after sterilization?

  No, the device is supplied for single-use and is not designed for reprocessing or reuse. Each unit is intended for one patient application only.

• What is the regulatory classification of this device?

  It is classified as a Class II prosthesis under product code JDI with special controls. It received FDA 510(k) clearance (K972460) as substantially equivalent to a predicate device.