PMA P010014S021
- Device
- OXFORD PARTIAL KNEE
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S021
- Product code
- NRA
- Decision date
- 2008-08-15
- Classification
- Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-constrained, Metal/polymer, Mobile Bearing
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- 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.
Current openFDA PMA Record#
- Device
- OXFORD PARTIAL KNEE
- Applicant
- Biomet Manufacturing Corp
- PMA number
- P010014
- Supplement
- S021
- Product code
- NRA
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Decision date
- 2008-08-15
- Decision code
- APPR
- Date received
- 2008-06-18
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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.