Osteonics Total Elbow System

• • Ongoing Z-3195-2026 FDA Class II ·initiated 30 Jul 2026

  Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.

510(k) Number

K980502 ↗

FDA Product Code

JDC

Device Class

Class II

Regulation

21 CFR Part 888.3150

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

• 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

• Osteonics 7000 Series Total Knee Tibial Components

  Class II

  FDA 510(k) K910990 Active Cleared 19 Jun 1991

See all devices from Osteonics Corp. →