BIPOLAR HIP DEVICE
FDA 510(k) clearance K833991 · decided 1984-01-30
Clearance details
- K-number
- K833991
- Device name
- BIPOLAR HIP DEVICE
- Applicant
- Zimmer
- Decision
- Substantially Equivalent
- Date received
- 1983-11-21
- Decision date
- 1984-01-30
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- KWY
- Device class
- 2
- Regulation number
- 888.3390
- 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 |
|---|---|---|
| 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
| Record | Firm | Date |
|---|---|---|
| Product 16 consists of all product under poduct code: KWY and same usage: Item no: 5001038 recall (Z-1114-2016) | Zimmer Manufacturing B.V. | 2016-03-12 |
| Bipolar Shell prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-po recall (Z-0845-2016) | Zimmer Biomet, Inc. | 2016-02-22 |
| Bipolar liners and Multipolar cups with the following dimensions in MM (38, 39, 40, 41, 42 recall (Z-1019-2014) | Zimmer, Inc. | 2014-02-20 |
| Multipolar Bipolar Cup METAL SHELL 38 MM OD through 71 MM OD. Indicated in fracture disloc recall (Z-0068-2014) | Zimmer, Inc. | 2013-10-25 |
| Multipolar Bipolar Cup Liner 22 mm LD.; Item 00-5001-040-22 Product Usage: The liner snaps recall (Z-0410-2013) | Zimmer, Inc. | 2012-11-20 |