COBALT-CHROMIUM-MOLYBDENUM (CO-CR-MO) ALLOY FEMORAL HEADS W/CO-NIDIUM SURFACE TREATMENT
FDA 510(k) clearance K960278 · decided 1996-07-25
Clearance details
- K-number
- K960278
- Device name
- COBALT-CHROMIUM-MOLYBDENUM (CO-CR-MO) ALLOY FEMORAL HEADS W/CO-NIDIUM SURFACE TREATMENT
- Applicant
- Zimmer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-01-19
- Decision date
- 1996-07-25
- Days to decision
- 188 days
- Clearance type
- Traditional
- Product code
- JDI
- Device class
- 2
- Regulation number
- 888.3350
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Zimmer
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Product 11 consists of all product under product code JDI , and same usage: Item no: 90260 recall (Z-1109-2016) | Zimmer Manufacturing B.V. | 2016-03-12 |
| Product 64 consists of all product under product code: JDI and same usage: Item no: 902605 recall (Z-1162-2016) | Zimmer Manufacturing B.V. | 2016-03-12 |
| Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 43MM DIA, ENDO FEMORAL HEAD 53MM DIA, END recall (Z-2548-2014) | Zimmer, Inc. | 2014-08-26 |
| 6 DEGREE COCR FEM HEAD (various sizes) and 6 DEG UNIPOLAR FEMORAL HE recall (Z-1033-2014) | Zimmer, Inc. | 2014-02-20 |
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 |