Oxford Partial Knee System
FDA premarket approval P010014/S070 · decided 2018-03-05
Approval details
- PMA number
- P010014
- Supplement
- S070
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Oxford Partial Knee System
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Applicant
- Biomet Manufacturing Corp
- Date received
- 2018-02-15
- Decision date
- 2018-03-05
- Days to decision
- 18 days
- Decision code
- APPR
- Product code
- NRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- Approval for updates to work instructions for inspection step of sterile and nonsterile packaging components.
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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® 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 |