Product code KWY
- Device name
- Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3390
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253357 | b-ONE® Bipolar Head | B-One Ortho, Corp. | 2026-04-13 |
| K243634 | Maxx Libertas Bipolar Hip Head (Bipolar Hip) | Maxx Orthopedics, Inc. | 2025-08-25 |
| K231526 | CORAIL Cemented Femoral Stem | Depuy Ireland UC | 2023-12-19 |
| K223441 | SpaceFlex Acetabular Cup | G21, S.R.L. | 2023-03-23 |
| K221794 | Vario-Cup System | Waldemar Link GmbH & Co. KG | 2022-07-20 |
| K220492 | COPAL exchange G hip spacer | Heraeus Medical GmbH | 2022-03-23 |
| K200709 | Kyocera Bipolar Hip System | Kyocera Medical Technologies, Inc. | 2020-04-17 |
| K192236 | Fitmore Hip Stem | Zimmer GmbH | 2019-11-05 |
| K191016 | COPAL exchange G Hip and Knee Spacers | Heraeus Medical GmbH | 2019-11-01 |
| K191297 | iNSitu Bipolar Hip System | Theken Companies, LLC | 2019-09-17 |
| K191569 | Implantcast ic-Bipolar Head System | Implantcast GmbH | 2019-08-28 |
| K183114 | Corin BiPolar-i | Corin U.S.A. Limited | 2019-06-05 |
| K173455 | SurgTech Bipolar Head System | Surgtech, Inc. | 2018-06-14 |
| K180130 | ELEOS™ Bipolar Acetabular System | Onkos Surgical, Inc. | 2018-02-23 |
| K163081 | 40-42mm BiPolar Head and 22mm Femoral Head | Signature Orthopaedics Pty, Ltd. | 2018-01-29 |
| K170072 | Fitmore® Hip Stem | Zimmer GmbH | 2017-02-07 |
| K152439 | U2 Bipolar Implant and 22mm Femoral Head | United Orthopedic Corporation | 2016-04-07 |
| K143113 | Klassic BiPolar System | Total Joint Orthopedics | 2015-01-28 |
| K132539 | RING-LOK MODULAR BIPOLAR SYSTEM | Implants International, Ltd. | 2014-02-07 |
| K131354 | RENOVIS BIPOLAR HIP SYSTEM | Renovis Surgical Technologies, LLC | 2013-09-19 |
| K123991 | DEPUY CORAIL AMT HIP PROSTHESIS | Depuy France S.A.S. | 2013-09-16 |
| K121509 | TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT | Tgm Medical, Inc. | 2012-11-05 |
| K112019 | BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP | Corentec Co., Ltd. | 2011-10-12 |
| K100761 | BIOPRO POLAR HEAD | Biopro, Inc. | 2010-12-03 |
| K101670 | UNITED U2 BIPOLAR IMPLANT | United Orthopedic Corp. | 2010-10-08 |
| K100151 | APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44 TO 60MM) | Omnlife Science | 2010-05-28 |
| K091967 | MEDACTA BIPOLAR HEAD | Medacta International S.A. | 2010-03-02 |
| K082468 | APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60) | Omni Life Science, Inc. | 2009-02-18 |
| K082705 | BIOPRO BIPOLAR HEAD, MODELS 18130-18152 | Biopro, Inc. | 2008-12-15 |
| K080979 | STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT | Biomet Manufacturing Corp | 2008-10-31 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07611996074901 | SL-PLUS | Smith & Nephew, Inc. | 2016-08-19 |
| 07611996074918 | SL-PLUS | Smith & Nephew, Inc. | 2016-08-19 |
| 07611996074925 | SL-PLUS | Smith & Nephew, Inc. | 2016-08-19 |
| 07611996074932 | SL-PLUS | Smith & Nephew, Inc. | 2016-08-19 |
| 07611996074949 | SL-PLUS | Smith & Nephew, Inc. | 2016-08-19 |
| 07611996074956 | SL-PLUS | Smith & Nephew, Inc. | 2016-08-19 |
| 07611996074963 | SL-PLUS | Smith & Nephew, Inc. | 2016-08-19 |
| 07611996074987 | SL-PLUS | Smith & Nephew, Inc. | 2016-08-19 |
| 07611996074994 | SL-PLUS | Smith & Nephew, Inc. | 2016-08-19 |
| 07611996075014 | SL-PLUS | Smith & Nephew, Inc. | 2016-08-19 |
| 07611996075021 | SL-PLUS | Smith & Nephew, Inc. | 2016-08-19 |
| 07611996081077 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996081015 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996081084 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996081107 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996081114 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996081121 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996081503 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996082500 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996085365 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996085372 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996081060 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996081053 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996081046 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996081039 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996081022 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996013849 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996081008 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996065343 | SL-PLUS | Smith & Nephew, Inc. | 2015-11-25 |
| 07611996045208 | MODULAR-PLUS | Smith & Nephew, Inc. | 2015-11-25 |