MODIFIED PROFILE HIP ACETABULAR PROSTHESIS
FDA 510(k) clearance K891408 · decided 1989-06-12
Clearance details
- K-number
- K891408
- Device name
- MODIFIED PROFILE HIP ACETABULAR PROSTHESIS
- Applicant
- Depuy, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-03-14
- Decision date
- 1989-06-12
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- JDX
- Device class
- 2
- Regulation number
- 888.4580
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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| PIEZOELECTRIC SYSTEM (K100410) | Satelec | 2010-04-28 |
| OSCAR 3 (K093805) | Orthosonics, Ltd. | 2010-02-19 |
| PIEZOSURGERY MEDICAL (K083284) | Piezosurgery S.R.L. | 2009-04-08 |
| OSCAR BONE RESECTOR (K083830) | Orthosonics, Ltd. | 2009-03-20 |
| LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX) (K072961) | Sra Developments, Ltd. | 2007-12-19 |
| OSCAR, MODEL OE3000DB (K051053) | Orthosonics, Ltd. | 2005-07-21 |
| ULTRA-DRIVE 3 (K031280) | Biomet, Inc. | 2003-09-22 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ATTUNE Revision Rotating Platform (RP) Knee System (P830055/S346) | Depuy, Inc. | 2025-12-18 |
| LCS Total Knee System (P830055/S355) | Depuy, Inc. | 2025-12-15 |
| LCS® Total Knee System (P830055/S354) | Depuy, Inc. | 2025-12-11 |
| LCS® Total Knee System (P830055/S353) | Depuy, Inc. | 2025-12-09 |
| LCS® Total Knee System (P830055/S352) | Depuy, Inc. | 2025-11-26 |
| LCS® Total Knee System (P830055/S350) | Depuy, Inc. | 2025-09-26 |
| LCS® Total Knee System (P830055/S349) | Depuy, Inc. | 2025-09-09 |
| LCS Total Knee System (P830055/S348) | Depuy, Inc. | 2025-08-29 |