PROFILE COLLARED HIP PROSTHESIS
FDA 510(k) clearance K904119 · decided 1990-10-11
Clearance details
- K-number
- K904119
- Device name
- PROFILE COLLARED HIP PROSTHESIS
- Applicant
- Depuy, Inc.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1990-09-06
- Decision date
- 1990-10-11
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- KWL
- Device class
- 2
- Regulation number
- 888.3360
- 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 |
|---|---|---|
| REMEDY POLY+PLUS SNAP FIT Acetabular Cup (K262290) | Osteoremedies, LLC | 2026-07-24 |
| Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement (K260536) | Depuy Ireland UC | 2026-05-15 |
| OsteoRemedies Hip Spacer System (K253675) | Osteoremedies, LLC | 2025-12-23 |
| InterSpace GV Hip Spacer (K252326) | Tecres S.P.A. | 2025-08-06 |
| Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer (K242865) | Biocomposites, Ltd. | 2025-06-12 |
| COPAL® exchange G hip spacer; COPAL® G+V (K234028) | Heraeus Medical GmbH | 2024-02-15 |
| UHR Bipolar Implants, Restoration GAP II Implants (K222632) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2022-10-21 |
| OsteoRemedies Hip Spacer System (K192995) | Osteoremedies, LLC | 2020-01-10 |
| REMEDY Acetabular Cup (K191981) | Osteoremedies, LLC | 2019-08-23 |
| REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement (K172906) | Osteoremedies, LLC | 2018-08-29 |
| Remedy Acetabular Cup (K173967) | Osteoremedies, LLC | 2018-02-22 |
| Evolve UniPolar Head (K143184) | Signature Orthopaedics Pty, Ltd. | 2015-03-17 |
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 |