KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Class II
FDA Device Classification
Classification Details
- Product Code
- KWY
- Device Class
- Class II
- Regulation Number
- 888.3390
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K243634 | maxx orthopedics | Maxx Libertas Bipolar Hip Head (Bipolar Hip) | August 25, 2025 |
| K231526 | depuy ireland uc | CORAIL Cemented Femoral Stem | December 19, 2023 |
| K223441 | g21 | SpaceFlex Acetabular Cup | March 23, 2023 |
| K221794 | waldemar link gmbh and co. kg | Vario-Cup System | July 20, 2022 |
| K220492 | heraeus medical | COPAL exchange G hip spacer | March 23, 2022 |
| K200709 | kyocera medical technologies | Kyocera Bipolar Hip System | April 17, 2020 |
| K192236 | zimmer | Fitmore Hip Stem | November 5, 2019 |
| K191016 | heraeus medical | COPAL exchange G Hip and Knee Spacers | November 1, 2019 |
| K191297 | theken companies | iNSitu Bipolar Hip System | September 17, 2019 |
| K191569 | implantcast | Implantcast ic-Bipolar Head System | August 28, 2019 |
| K183114 | corin u.s.a. limited | Corin BiPolar-i | June 5, 2019 |
| K173455 | surgtech | SurgTech Bipolar Head System | June 14, 2018 |
| K180130 | onkos surgical | ELEOS Bipolar Acetabular System | February 23, 2018 |
| K163081 | signature orthopaedics pty | 40-42mm BiPolar Head and 22mm Femoral Head | January 29, 2018 |
| K170072 | zimmer | Fitmore® Hip Stem | February 7, 2017 |
| K152439 | united orthopedic corporation | U2 Bipolar Implant and 22mm Femoral Head | April 7, 2016 |
| K143113 | total joint orthopedics | Klassic BiPolar System | January 28, 2015 |
| K132539 | implants international | RING-LOK MODULAR BIPOLAR SYSTEM | February 7, 2014 |
| K131354 | renovis surgical technologies | RENOVIS BIPOLAR HIP SYSTEM | September 19, 2013 |
| K123991 | depuy france | DEPUY CORAIL AMT HIP PROSTHESIS | September 16, 2013 |