Osteonics Hip Revision Wedges

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

510(k) Number

K905406 ↗

FDA Product Code

JDI

Device Class

Class II

Regulation

21 CFR Part 888.3350

Advisory Committee

Orthopedic

FDA Decision

SN

• 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 are the Osteonics Hip Revision Wedges used for?

  The Osteonics Hip Revision Wedges are used in hip revision procedures, providing a solution for orthopedic applications.

• What is the regulatory status of the Osteonics Hip Revision Wedges?

  The device has been cleared through the FDA 510(k) authorization, specifically K905406, indicating substantial equivalence for some indications.

• Who supplies the Osteonics Hip Revision Wedges?

  The Osteonics Hip Revision Wedges are supplied by Osteonics Corp.