KWY · Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Orthopedic · 21 CFR 888.3390 · Class 2
Overview
| Product Code | KWY |
|---|---|
| Device Name | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented |
| Regulation | 21 CFR 888.3390 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 99)
Showing 20 most recent of 99 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253357 | b-ONE® Bipolar Head | B-One Ortho, Corp. | Apr 13, 2026 | SESE |
| K243634 | Maxx Libertas Bipolar Hip Head (Bipolar Hip) | Maxx Orthopedics, Inc. | Aug 25, 2025 | SESE |
| K231526 | CORAIL Cemented Femoral Stem | Depuy Ireland UC | Dec 19, 2023 | SESE |
| K223441 | SpaceFlex Acetabular Cup | G21, S.R.L. | Mar 23, 2023 | SESE |
| K221794 | Vario-Cup System | Waldemar Link GmbH & Co. KG | Jul 20, 2022 | SESE |
| K220492 | COPAL exchange G hip spacer | Heraeus Medical GmbH | Mar 23, 2022 | SESE |
| K200709 | Kyocera Bipolar Hip System | Kyocera Medical Technologies, Inc. | Apr 17, 2020 | SESE |
| K192236 | Fitmore Hip Stem | Zimmer GmbH | Nov 5, 2019 | SESE |
| K191016 | COPAL exchange G Hip and Knee Spacers | Heraeus Medical GmbH | Nov 1, 2019 | SESE |
| K191297 | iNSitu Bipolar Hip System | Theken Companies, LLC | Sep 17, 2019 | SESE |
| K191569 | Implantcast ic-Bipolar Head System | Implantcast GmbH | Aug 28, 2019 | SESE |
| K183114 | Corin BiPolar-i | Corin U.S.A. Limited | Jun 5, 2019 | SESE |
| K173455 | SurgTech Bipolar Head System | Surgtech, Inc. | Jun 14, 2018 | SESE |
| K180130 | ELEOS Bipolar Acetabular System | Onkos Surgical, Inc. | Feb 23, 2018 | SESE |
| K163081 | 40-42mm BiPolar Head and 22mm Femoral Head | Signature Orthopaedics Pty, Ltd. | Jan 29, 2018 | SESE |
| K170072 | Fitmore® Hip Stem | Zimmer GmbH | Feb 7, 2017 | SESE |
| K152439 | U2 Bipolar Implant and 22mm Femoral Head | United Orthopedic Corporation | Apr 7, 2016 | SESE |
| K143113 | Klassic BiPolar System | Total Joint Orthopedics | Jan 28, 2015 | SESE |
| K132539 | RING-LOK MODULAR BIPOLAR SYSTEM | Implants International, Ltd. | Feb 7, 2014 | SESE |
| K131354 | RENOVIS BIPOLAR HIP SYSTEM | Renovis Surgical Technologies, LLC | Sep 19, 2013 | SESE |
Top Applicants
- Johnson & Johnson Professionals, Inc. — 9 clearances
- Ortho Development Corp. — 5 clearances
- Biomet, Inc. — 5 clearances
- Howmedica Corp. — 4 clearances
- 3M Company — 4 clearances
