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. |
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Device | OXFORD PARTIAL KNEE |
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 | S021 |
Date Received | 06/18/2008 |
Decision Date | 08/15/2008 |
Product Code |
NRA |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF COMPUTER AIDED SURGERY (CAS) NAVIGATION SURGICAL INSTRUMENTS FOR USE WITH THE BRAINLAB UNI-KNEE IMAGE GUIDANCE SYSTEM FOR USE WITH THE OXFORD PARTIAL KNEE SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME OXFORD PARTIAL KNEE SYSTEM AND IS INTENDED FOR USE IN INDIVIDUALS WITH OSTEOARTHRITIS OR AVASCULAR NECROSIS LIMITED TO THE MEDIAL COMPARTMENT OF THE KNEE AND IS INTENDED TO BE IMPLANTED WITH BONE CEMENT. |
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