OXFORD PARTIAL KNEE
FDA premarket approval P010014/S021 · decided 2008-08-15
Approval details
- PMA number
- P010014
- Supplement
- S021
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- OXFORD PARTIAL KNEE
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Applicant
- Biomet Manufacturing Corp
- Date received
- 2008-06-18
- Decision date
- 2008-08-15
- Days to decision
- 58 days
- Decision code
- APPR
- Product code
- NRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- 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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