KWL · Prosthesis, Hip, Hemi-, Femoral, Metal
Orthopedic · 21 CFR 888.3360 · Class 2
Overview
| Product Code | KWL |
|---|---|
| Device Name | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Regulation | 21 CFR 888.3360 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 106)
Showing 20 most recent of 106 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253675 | OsteoRemedies Hip Spacer System | Osteoremedies, LLC | Dec 23, 2025 | SESE |
| K252326 | InterSpace GV Hip Spacer | Tecres S.P.A. | Aug 6, 2025 | SESE |
| K242865 | Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer | Biocomposites, Ltd. | Jun 12, 2025 | SESE |
| K234028 | COPAL® exchange G hip spacer; COPAL® G+V | Heraeus Medical GmbH | Feb 15, 2024 | SESE |
| K222632 | UHR Bipolar Implants, Restoration GAP II Implants | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Oct 21, 2022 | SESE |
| K192995 | OsteoRemedies Hip Spacer System | Osteoremedies, LLC | Jan 10, 2020 | SESE |
| K191981 | REMEDY Acetabular Cup | Osteoremedies, LLC | Aug 23, 2019 | SESE |
| K172906 | REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement | Osteoremedies, LLC | Aug 29, 2018 | SESE |
| K173967 | Remedy Acetabular Cup | Osteoremedies, LLC | Feb 22, 2018 | SESE |
| K143184 | Evolve UniPolar Head | Signature Orthopaedics Pty, Ltd. | Mar 17, 2015 | SESE |
| K112470 | 2GC HIP/KNEE MODULAR SPACER | Mandell Horwitz Consultants, LLC | Apr 5, 2012 | SESE |
| K101356 | Spacer-G and Spacer-K | Tecres S.P.A. | Sep 20, 2011 | SESE |
| K111911 | CORIN OPTIMOM MODULAR HEAD | Corin USA | Aug 4, 2011 | SESE |
| K062273 | SPACER-G TEMPORARY HIP PROSTHESIS | Tecres S.P.A. | May 22, 2008 | SESE |
| K071471 | CORIN ADAPTOR SLEEVE | Howmedica Osteonics Corp. | Sep 10, 2007 | SESE |
| K063791 | CORIN UNIPOLAR MODULAR HEAD | Corin USA | Apr 3, 2007 | SESE |
| K062408 | SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD | Smith & Nephew, Inc. | Sep 12, 2006 | SESE |
| K061243 | SMITH & NEPHEW MODULAR FEMORAL HEAD | Smith & Nephew, Inc. | Jul 17, 2006 | SESE |
| K042973 | SOLITUDE UNIPOLAR HEAD | Ortho Development Corp. | Jan 27, 2005 | SESE |
| K031841 | SPACER G TEMPORARY HIP PROSTHESIS | Exactech, Inc. | Jan 22, 2004 | SESE |
Top Applicants
- Osteonics Corp. — 8 clearances
- Depuy, Inc. — 7 clearances
- Biomet, Inc. — 6 clearances
- Osteoremedies, LLC — 5 clearances
- Howmedica Corp. — 5 clearances
