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- Meniscal bearings
• 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: S062
• Date Received: 05/05/2017
• Decision Date: 05/16/2017
• Product Code: NRA
• Advisory Committee: Orthopedic
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
Harmonize device cleanliness testing methods and parameters across the global organization and change of location of residual testing.