Oxford Cementless Partial Knee System
FDA premarket approval P010014/S105 · decided 2024-11-22
Approval details
- PMA number
- P010014
- Supplement
- S105
- Supplement type
- Panel Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Oxford Cementless Partial Knee System
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Applicant
- Biomet Manufacturing Corp
- Date received
- 2023-06-05
- Decision date
- 2024-11-22
- Days to decision
- 536 days
- Decision code
- APPR
- Product code
- NRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- The Oxford Cementless Partial Knee System is indicated for use in unilateral knee procedures with osteoarthritis or avascular necrosis limited to the medial compartment of the knee. It is intended to be implanted without the application of bone cement for patients whose clinical condition would benefit from a shorter surgical time compared to the cemented implant.
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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 |