Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation System
FDA 510(k) clearance K150818 · decided 2015-05-01
Clearance details
- K-number
- K150818
- Device name
- Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation System
- Applicant
- Zimmer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-03-27
- Decision date
- 2015-05-01
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- KTT
- Device class
- 2
- Regulation number
- 888.3030
- 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 |
|---|---|---|
| VersaFx Femoral Fixation System Hex head compression screw 4.7 mm dia. 2 inch (51 mm) leng recall (Z-1682-2016) | Zimmer Manufacturing B.V. | 2016-05-16 |
| Product 20 consists of all prod oct under poduct code: KTT and same usage: Item no: 471162 recall (Z-1118-2016) | Zimmer Manufacturing B.V. | 2016-03-12 |
| Product 31 consists of all product under product code: KTT and same usage: Item no: 118113 recall (Z-1129-2016) | Zimmer Manufacturing B.V. | 2016-03-12 |
| Product 41 consists of all product under product code: KTT and same usage: Item no: 119301 recall (Z-1139-2016) | Zimmer Manufacturing B.V. | 2016-03-12 |
| Product 65 consists of all product under product code: KTT and same usage: Item no: 119413 recall (Z-1163-2016) | Zimmer Manufacturing B.V. | 2016-03-12 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Nexgen LPS Femoral and Tibial Knee components (P060037/S098) | Zimmer, Inc. | 2026-07-20 |
| Creep Pressure Test Update for the Nexgen LPS Bearing Knee (P060037/S097) | Zimmer, Inc. | 2026-07-20 |
| NexGen® LPS-Flex / LPS Mobile Bearing Knee System (P060037/S096) | Zimmer, Inc. | 2026-01-16 |
| NexGen© LPSFlex/ LPS Mobile Bearing Knee System (P060037/S095) | Zimmer, Inc. | 2025-08-18 |
| NexGen© LPSFlex/LPS Mobile Bearing Knee System (P060037/S093) | Zimmer, Inc. | 2025-04-09 |
| NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S094) | Zimmer, Inc. | 2025-04-01 |
| NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM (P060037/S092) | Zimmer, Inc. | 2024-12-12 |
| NexGen® LPS-Flex LPS-Mobile Bearing Knee (P060037/S091) | Zimmer, Inc. | 2024-07-05 |