Oxford Partial Knee System
FDA premarket approval P010014/S100 · decided 2020-12-07
Approval details
- PMA number
- P010014
- Supplement
- S100
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Oxford Partial Knee System
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Applicant
- Biomet Manufacturing Corp
- Date received
- 2020-10-16
- Decision date
- 2020-12-07
- Days to decision
- 52 days
- Decision code
- APPR
- Product code
- NRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- Modification to the labeling to reflect the findings of the Post-Approval Study (PAS) Report, for the Oxford Partial Knee System.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Patient Specific Planning Solution™ 3D Bone Models (K230540) | Biomet Manufacturing Corp | 2023-07-25 |
| Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System (K214001) | Biomet Manufacturing Corp | 2023-03-15 |
| Comprehensive® Convertible Glenoid - Vivacit-E Liner (K211729) | Biomet Manufacturing Corp | 2021-11-04 |
| 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 |