Osteonics Restoration Monolithic II Slotted Hip Stem Series

• • Terminated Z-1677-2012 FDA Unclassified (pre-2012) ·initiated 27 Oct 2011

  An incorrect laser mark was noted on specific lots of product, incorrectly implying a stem size of 9, when the product is actually size 8.

510(k) Number

K951671 ↗

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. →