VANGUARD COMPLETE KNEE SYSTEM
FDA 510(k) clearance K113550 · decided 2012-02-29
Clearance details
- K-number
- K113550
- Device name
- VANGUARD COMPLETE KNEE SYSTEM
- Applicant
- Biomet Manufacturing Corp
- Decision
- Substantially Equivalent
- Date received
- 2011-12-01
- Decision date
- 2012-02-29
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- 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 |
|---|---|---|
| (1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replac recall (Z-1042-2023) | Biomet, Inc. | 2023-01-30 |
| (1) Vanguard Knee System PS Open Box Femoral; Left; 57.5 mm. Intended for Knee joint repla recall (Z-1043-2023) | Biomet, Inc. | 2023-01-30 |
| Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers EP-183664, EP- recall (Z-2289-2018) | Zimmer Biomet, Inc. | 2018-06-04 |
| Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint recall (Z-2183-2018) | Zimmer Biomet, Inc. | 2018-06-01 |
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 |