KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Class II
FDA product code KWY covers "Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented", a Class II medical device regulated under 21 CFR 888.3390. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K253357 | b-one ortho | b-ONE® Bipolar Head | April 13, 2026 |
| 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 |