OXFORD MENISCAL UNICOMPARTMENTAL KNEE
FDA premarket approval P010014/S017 · decided 2008-02-20
Approval details
- PMA number
- P010014
- Supplement
- S017
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OXFORD MENISCAL UNICOMPARTMENTAL KNEE
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Applicant
- Biomet Manufacturing Corp
- Date received
- 2007-08-22
- Decision date
- 2008-02-20
- Days to decision
- 182 days
- Decision code
- APPR
- Product code
- NRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- APPROVAL FOR A PRODUCT LINE EXTENSION TO INCLUDE A NEW SERIES OF FEMORAL COMPONENTS DESIGNED TO ADD AN ADDITIONAL FIXATION PEG AND EXTEND THE ARTICULAR SURFACE 20 DEGREES ANTERIORLY.
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510(k) clearances by this applicant
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|---|---|---|
| Patient Specific Planning Solution™ 3D Bone Models (K230540) | Biomet Manufacturing Corp | 2023-07-25 |
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| Comprehensive Vault Reconstruction System (K202232) | Biomet Manufacturing Corp | 2021-02-19 |
| Comprehensive Shoulder System (K193038) | Biomet Manufacturing Corp | 2020-10-28 |
| Comprehensive Nano Stemless Shoulder (K182516) | Biomet Manufacturing Corp | 2019-04-22 |
| Comprehensive Reverse Shoulder System (K181611) | Biomet Manufacturing Corp | 2018-09-24 |
| Comprehensive Segmental Revision System (SRS) (K173411) | Biomet Manufacturing Corp | 2018-02-08 |