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Device | OXFORD(TM) MENISCAL UNICOMPARTMENTAL 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 |
Date Received | 03/01/2001 |
Decision Date | 04/21/2004 |
Product Code |
NRA |
Docket Number | 04M-0200 |
Notice Date | 05/05/2004 |
Advisory Committee |
Orthopedic |
Expedited Review Granted? | No |
Combination Product | No |
Predetermined Change Control Plan Authorized | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (PHASE 3). THE DEVICE IS INDICATED FOR USE IN PATIENTS WITH OSTEOARTHRITIS OR AVASCULAR NECROSIS LIMITED TO THE MEDIAL COMPARTMENT OF THE KNEE AND INTENDED TO BE IMPLANTED WITH BONE CEMENT. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S008 S011 S012 S029 S027 S028 S002 S016 S017 S018 S001 S014 S015 S020 S021 S022 S071 S072 S073 S074 S075 S101 S066 S067 S062 S063 S054 S060 S061 S058 S059 S055 S026 S024 S030 S031 S032 S033 S035 S036 S037 S048 S049 S050 S051 S052 S053 S103 S039 S040 S041 S042 S043 S044 S045 S046 S047 S003 S004 S005 S006 S009 S056 S057 S087 S088 S089 S094 S096 S084 S104 S108 S065 S069 S076 S077 S068 S082 S079 S080 S081 S070 S090 S091 S092 S093 S083 S097 S098 S085 S086 S102 S100 S107 S106 S105 |