ENHANCED MODULAR AUSTIN MOORE HIP
FDA 510(k) clearance K936044 · decided 1994-04-26
Clearance details
- K-number
- K936044
- Device name
- ENHANCED MODULAR AUSTIN MOORE HIP
- Applicant
- Zimmer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-12-20
- Decision date
- 1994-04-26
- Days to decision
- 127 days
- Clearance type
- Traditional
- Product code
- KMC
- Device class
- 2
- Regulation number
- 888.3340
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| APR REVISION HIP PROSTHESIS, FEMORAL COMPONENT (K853524) | Intermedics Orthopedics | 1985-11-22 |
| MALLORY/HEAD TOTAL HIP SYSTEM (K853259) | Biomet, Inc. | 1985-11-01 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MODULAR AUSTIN MOORE FENE. Item codes starting with 45502001, 455503001 and 455504001 recall (Z-1018-2014) | Zimmer, Inc. | 2014-02-20 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| 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 |
| NexGen® LPS-Flex / LPS Mobile Bearing Knee System (P060037/S090) | Zimmer, Inc. | 2024-05-17 |
| NexGen LPS-Flex/LPS Mobile Bearing Knee System (P060037/S089) | Zimmer, Inc. | 2024-04-04 |
| NexGen® LPS-Flex/LPS Mobile Bearing Knee System (P060037/S088) | Zimmer, Inc. | 2024-02-13 |