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/productcode/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](/device/K253357.md) | b-ONE® Bipolar Head | B-One Ortho, Corp. | Apr 13, 2026 | SESE |
| [K243634](/device/K243634.md) | Maxx Libertas Bipolar Hip Head (Bipolar Hip) | Maxx Orthopedics, Inc. | Aug 25, 2025 | SESE |
| [K231526](/device/K231526.md) | CORAIL Cemented Femoral Stem | Depuy Ireland UC | Dec 19, 2023 | SESE |
| [K223441](/device/K223441.md) | SpaceFlex Acetabular Cup | G21, S.R.L. | Mar 23, 2023 | SESE |
| [K221794](/device/K221794.md) | Vario-Cup System | Waldemar Link GmbH & Co. KG | Jul 20, 2022 | SESE |
| [K220492](/device/K220492.md) | COPAL exchange G hip spacer | Heraeus Medical GmbH | Mar 23, 2022 | SESE |
| [K200709](/device/K200709.md) | Kyocera Bipolar Hip System | Kyocera Medical Technologies, Inc. | Apr 17, 2020 | SESE |
| [K192236](/device/K192236.md) | Fitmore Hip Stem | Zimmer GmbH | Nov 5, 2019 | SESE |
| [K191016](/device/K191016.md) | COPAL exchange G Hip and Knee Spacers | Heraeus Medical GmbH | Nov 1, 2019 | SESE |
| [K191297](/device/K191297.md) | iNSitu Bipolar Hip System | Theken Companies, LLC | Sep 17, 2019 | SESE |
| [K191569](/device/K191569.md) | Implantcast ic-Bipolar Head System | Implantcast GmbH | Aug 28, 2019 | SESE |
| [K183114](/device/K183114.md) | Corin BiPolar-i | Corin U.S.A. Limited | Jun 5, 2019 | SESE |
| [K173455](/device/K173455.md) | SurgTech Bipolar Head System | Surgtech, Inc. | Jun 14, 2018 | SESE |
| [K180130](/device/K180130.md) | ELEOS™ Bipolar Acetabular System | Onkos Surgical, Inc. | Feb 23, 2018 | SESE |
| [K163081](/device/K163081.md) | 40-42mm BiPolar Head and 22mm Femoral Head | Signature Orthopaedics Pty, Ltd. | Jan 29, 2018 | SESE |
| [K170072](/device/K170072.md) | Fitmore® Hip Stem | Zimmer GmbH | Feb 7, 2017 | SESE |
| [K152439](/device/K152439.md) | U2 Bipolar Implant and 22mm Femoral Head | United Orthopedic Corporation | Apr 7, 2016 | SESE |
| [K143113](/device/K143113.md) | Klassic BiPolar System | Total Joint Orthopedics | Jan 28, 2015 | SESE |
| [K132539](/device/K132539.md) | RING-LOK MODULAR BIPOLAR SYSTEM | Implants International, Ltd. | Feb 7, 2014 | SESE |
| [K131354](/device/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/productcode/KWY](https://fda.innolitics.com/productcode/KWY)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com