OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM
FDA premarket approval P010014 · decided 2004-04-21
Approval details
- PMA number
- P010014
- Trade name
- OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM
- Generic name
- Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
- Applicant
- Biomet Manufacturing Corp
- Date received
- 2001-03-01
- Decision date
- 2004-04-21
- Days to decision
- 1147 days
- Decision code
- APPR
- Product code
- NRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- APPROVAL FOR THE OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (PHASE 3). THE DEVICE IS INDICATED FOR USE IN PATIENTS WITH OSTEOARTHRITIS OR AVASCULAR NECROSIS LIMITED TO THE MEDIAL COMPARTMENT OF THE KNEE AND INTENDED TO BE IMPLANTED WITH BONE CEMENT.
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 |