KWL — Prosthesis, Hip, Hemi-, Femoral, Metal Class II
FDA product code KWL covers "Prosthesis, Hip, Hemi-, Femoral, Metal", a Class II medical device regulated under 21 CFR 888.3360. 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
- KWL
- Device Class
- Class II
- Regulation Number
- 888.3360
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260536 | depuy ireland uc | Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement | May 15, 2026 |
| K253675 | osteoremedies | OsteoRemedies Hip Spacer System | December 23, 2025 |
| K252326 | tecres | InterSpace GV Hip Spacer | August 6, 2025 |
| K242865 | biocomposites | Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer | June 12, 2025 |
| K234028 | heraeus medical | COPAL® exchange G hip spacer; COPAL® G+V | February 15, 2024 |
| K222632 | howmedica osteonics corp., dba stryker orthopaedics | UHR Bipolar Implants, Restoration GAP II Implants | October 21, 2022 |
| K192995 | osteoremedies | OsteoRemedies Hip Spacer System | January 10, 2020 |
| K191981 | osteoremedies | REMEDY Acetabular Cup | August 23, 2019 |
| K172906 | osteoremedies | REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement | August 29, 2018 |
| K173967 | osteoremedies | Remedy Acetabular Cup | February 22, 2018 |
| K143184 | signature orthopaedics pty | Evolve UniPolar Head | March 17, 2015 |
| K112470 | mandell horwitz consultants | 2GC HIP/KNEE MODULAR SPACER | April 5, 2012 |
| K101356 | tecres | Spacer-G and Spacer-K | September 20, 2011 |
| K111911 | corin usa | CORIN OPTIMOM MODULAR HEAD | August 4, 2011 |
| K062273 | tecres | SPACER-G TEMPORARY HIP PROSTHESIS | May 22, 2008 |
| K071471 | howmedica osteonics | CORIN ADAPTOR SLEEVE | September 10, 2007 |
| K063791 | corin usa | CORIN UNIPOLAR MODULAR HEAD | April 3, 2007 |
| K062408 | smith and nephew | SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD | September 12, 2006 |
| K061243 | smith and nephew | SMITH & NEPHEW MODULAR FEMORAL HEAD | July 17, 2006 |
| K042973 | ortho development | SOLITUDE UNIPOLAR HEAD | January 27, 2005 |