Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3390](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3390) → KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented # KWY · Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented _Orthopedic · 21 CFR 888.3390 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWY ## Overview - **Product Code:** KWY - **Device Name:** Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented - **Regulation:** [21 CFR 888.3390](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3390) - **Device Class:** 2 - **Review Panel:** [Orthopedic](/submissions/OR) - **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](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWY/K253357.md) | b-ONE® Bipolar Head | B-One Ortho, Corp. | Apr 13, 2026 | SESE | | [K243634](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWY/K243634.md) | Maxx Libertas Bipolar Hip Head (Bipolar Hip) | Maxx Orthopedics, Inc. | Aug 25, 2025 | SESE | | [K231526](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWY/K231526.md) | CORAIL Cemented Femoral Stem | Depuy Ireland UC | Dec 19, 2023 | SESE | | [K223441](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWY/K223441.md) | SpaceFlex Acetabular Cup | G21, S.R.L. | Mar 23, 2023 | SESE | | [K221794](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWY/K221794.md) | Vario-Cup System | Waldemar Link GmbH & Co. KG | Jul 20, 2022 | SESE | | [K220492](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWY/K220492.md) | COPAL exchange G hip spacer | Heraeus Medical GmbH | Mar 23, 2022 | SESE | | [K200709](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWY/K200709.md) | Kyocera Bipolar Hip System | Kyocera Medical Technologies, Inc. | Apr 17, 2020 | SESE | | [K192236](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWY/K192236.md) | Fitmore Hip Stem | Zimmer GmbH | Nov 5, 2019 | SESE | | [K191016](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWY/K191016.md) | COPAL exchange G Hip and Knee Spacers | Heraeus Medical GmbH | Nov 1, 2019 | SESE | | [K191297](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWY/K191297.md) | iNSitu Bipolar Hip System | Theken Companies, LLC | Sep 17, 2019 | SESE | | [K191569](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWY/K191569.md) | Implantcast ic-Bipolar Head System | Implantcast GmbH | Aug 28, 2019 | SESE | | [K183114](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWY/K183114.md) | Corin BiPolar-i | Corin U.S.A. Limited | Jun 5, 2019 | SESE | | [K173455](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWY/K173455.md) | SurgTech Bipolar Head System | Surgtech, Inc. | Jun 14, 2018 | SESE | | [K180130](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWY/K180130.md) | ELEOS™ Bipolar Acetabular System | Onkos Surgical, Inc. | Feb 23, 2018 | SESE | | [K163081](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWY/K163081.md) | 40-42mm BiPolar Head and 22mm Femoral Head | Signature Orthopaedics Pty, Ltd. | Jan 29, 2018 | SESE | | [K170072](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWY/K170072.md) | Fitmore® Hip Stem | Zimmer GmbH | Feb 7, 2017 | SESE | | [K152439](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWY/K152439.md) | U2 Bipolar Implant and 22mm Femoral Head | United Orthopedic Corporation | Apr 7, 2016 | SESE | | [K143113](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWY/K143113.md) | Klassic BiPolar System | Total Joint Orthopedics | Jan 28, 2015 | SESE | | [K132539](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWY/K132539.md) | RING-LOK MODULAR BIPOLAR SYSTEM | Implants International, Ltd. | Feb 7, 2014 | SESE | | [K131354](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWY/K131354.md) | RENOVIS BIPOLAR HIP SYSTEM | Renovis Surgical Technologies, LLC | Sep 19, 2013 | SESE | ## Top Applicants - Johnson & Johnson Professionals, Inc. — 9 clearances - Biomet, Inc. — 5 clearances - Ortho Development Corp. — 5 clearances - 3M Company — 4 clearances - Howmedica Corp. — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWY](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWY) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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