SELF-CENTERING HIP
FDA 510(k) clearance K812672 · decided 1981-10-08
Clearance details
- K-number
- K812672
- Device name
- SELF-CENTERING HIP
- Applicant
- Depuy, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-09-22
- Decision date
- 1981-10-08
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- KWY
- Device class
- 2
- Regulation number
- 888.3390
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mchenry, IL, 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 |
|---|---|---|
| b-ONE® Bipolar Head (K253357) | B-One Ortho, Corp. | 2026-04-13 |
| Maxx Libertas Bipolar Hip Head (Bipolar Hip) (K243634) | Maxx Orthopedics, Inc. | 2025-08-25 |
| CORAIL Cemented Femoral Stem (K231526) | Depuy Ireland UC | 2023-12-19 |
| SpaceFlex Acetabular Cup (K223441) | G21, S.R.L. | 2023-03-23 |
| Vario-Cup System (K221794) | Waldemar Link GmbH & Co. KG | 2022-07-20 |
| COPAL exchange G hip spacer (K220492) | Heraeus Medical GmbH | 2022-03-23 |
| Kyocera Bipolar Hip System (K200709) | Kyocera Medical Technologies, Inc. | 2020-04-17 |
| Fitmore Hip Stem (K192236) | Zimmer GmbH | 2019-11-05 |
| COPAL exchange G Hip and Knee Spacers (K191016) | Heraeus Medical GmbH | 2019-11-01 |
| iNSitu Bipolar Hip System (K191297) | Theken Companies, LLC | 2019-09-17 |
| Implantcast ic-Bipolar Head System (K191569) | Implantcast GmbH | 2019-08-28 |
| Corin BiPolar-i (K183114) | Corin U.S.A. Limited | 2019-06-05 |
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 |