Oxford Partial Knee
FDA premarket approval P010014/S104 · decided 2023-04-06
Approval details
- PMA number
- P010014
- Supplement
- S104
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Oxford Partial Knee
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Applicant
- Biomet Manufacturing Corp
- Date received
- 2023-03-07
- Decision date
- 2023-04-06
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- Introduction of alternative manufacturing materials that are used in Non-Destructive Testing (NDT), specifically the Fluorescent Penetrant Inspection (FPI) on the castings of Oxford Partial Knee tibial tray and twin peg femoral components.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |