MODULAR HYBRID GLENOID
FDA 510(k) clearance K060694 · decided 2006-12-11
Clearance details
- K-number
- K060694
- Device name
- MODULAR HYBRID GLENOID
- Applicant
- Biomet Manufacturing Corp
- Decision
- Substantially Equivalent
- Date received
- 2006-03-15
- Decision date
- 2006-12-11
- Days to decision
- 271 days
- Clearance type
- Traditional
- Product code
- KWS
- Device class
- 2
- Regulation number
- 888.3660
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| various polyethylene implants Extremities, Shoulders and Elbows BioModular Shoulder System recall (Z-1859-2017) | Zimmer Biomet, Inc. | 2017-03-27 |
| PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, recall (Z-0660-2013) | Biomet, Inc. | 2013-01-09 |
| Biomet Hybrid Glenoid Boss Cutter; item 406150. - Surgical instrument used to prepare the recall (Z-1658-2008) | Biomet, Inc. | 2008-09-16 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Oxford Knee System (P010014/S111) | Biomet Manufacturing Corp | 2025-08-07 |
| Oxford Partial Knee System (P010014/S109) | Biomet Manufacturing Corp | 2025-08-07 |
| OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (P010014/S110) | Biomet Manufacturing Corp | 2025-06-24 |
| Oxford® Partial Knee System (P010014/S107) | Biomet Manufacturing Corp | 2024-11-22 |
| Oxford Cementless Partial Knee System (P010014/S105) | Biomet Manufacturing Corp | 2024-11-22 |
| Oxford Partial Knee System (P010014/S108) | Biomet Manufacturing Corp | 2024-11-18 |
| Oxford® Partial Knee System (P010014/S106) | Biomet Manufacturing Corp | 2024-08-19 |
| Oxford Partial Knee (P010014/S104) | Biomet Manufacturing Corp | 2023-04-06 |