Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: OXFORD PARTIAL KNEE SYSTEM
• Generic Name: Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
• Applicant: BIOMET MANUFACTURING CORP.; 56 EAST BELL DRIVE; P.O. BOX 587; WARSAW, IN 46581-0587
• PMA Number: P010014
• Supplement Number: S029
• Date Received: 10/26/2010
• Decision Date: 05/03/2011
• Product Code: NRA
• Advisory Committee: Orthopedic
• Supplement Type: 135 Review Track For 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
ADDITIONAL MANUFACTURING STEPS FOR THE OXFORD® PARTIAL KNEE TWIN PEG FEMORAL COMPONENTS.