FDA 510(k) Applications for Medical Device Product Code "KWL"
(Prosthesis, Hip, Hemi-, Femoral, Metal)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K984028 | BIOMET, INC. | THE NEW BIO-MOORE ENDO HEADS | 01/19/1999 |
| K111911 | CORIN U.S.A. | CORIN OPTIMOM MODULAR HEAD | 08/04/2011 |
| K063791 | CORIN USA | CORIN UNIPOLAR MODULAR HEAD | 04/03/2007 |
| K030972 | DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. | FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH) | 05/30/2003 |
| K973614 | ENCORE ORTHOPEDICS, INC. | FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEEVES | 12/18/1997 |
| K960538 | EXACTECH, INC. | OPTEON UNIPOLAR | 03/27/1996 |
| K031841 | EXACTECH, INC. | SPACER G TEMPORARY HIP PROSTHESIS | 01/22/2004 |
| K030205 | HAYES MEDICAL, INC. | CONSENSUS UNIPOLAR HEAD, COCR | 04/01/2003 |
| K071471 | HOWMEDICA OSTEONICS CORP | CORIN ADAPTOR SLEEVE | 09/10/2007 |
| K992570 | HOWMEDICA OSTEONICS CORP. | UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE | 09/01/1999 |
| K014226 | HOWMEDICA OSTEONICS CORP. | UNITRAX MODULAR UNIPOLAR SYSTEM | 01/25/2002 |
| K222632 | Howmedica Osteonics Corp., dba Stryker Orthopaedics | UHR Bipolar Implants, Restoration GAP II Implants | 10/21/2022 |
| K965198 | JOHNSON & JOHNSON INTERNATIONAL | ULTIMA TPS CEMENTED STEM | 07/23/1997 |
| K955385 | JOHNSON & JOHNSON PROFESSIONALS, INC. | JOHNSON & JOHNSON AUSTIN MOORE STEM | 01/30/1996 |
| K965156 | JOHNSON & JOHNSON PROFESSIONALS, INC. | ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES | 01/24/1997 |
| K112470 | MANDELL HORWITZ CONSULTANTS LLC | 2GC HIP/KNEE MODULAR SPACER | 04/05/2012 |
| K042973 | ORTHO DEVELOPMENT CORP. | SOLITUDE UNIPOLAR HEAD | 01/27/2005 |
| K962646 | ORTHOPAEDIC INNOVATIONS, INC. | PRIME MODULAR ENDO HEAD | 09/23/1996 |
| K974807 | OSTEONICS CORP. | OSTEO AUSTIN MOORE ENDOPROSTHESIS SYSTEM | 03/16/1998 |
| K984585 | OSTEONICS CORP. | OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE | 02/24/1999 |
| K173967 | Osteoremedies LLC | Remedy Acetabular Cup | 02/22/2018 |
| K192995 | OsteoRemedies, LLC | OsteoRemedies Hip Spacer System | 01/10/2020 |
| K191981 | OsteoRemedies, LLC | REMEDY Acetabular Cup | 08/23/2019 |
| K172906 | OsteoRemedies, LLC | REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement | 08/29/2018 |
| K990309 | PLUS ORTHOPEDICS | PLUS FRACTURE HEAD PROSTHESIS | 03/15/1999 |
| K143184 | Signature Orthopaedics Pty Ltd. | Evolve UniPolar Head | 03/17/2015 |
| K062408 | SMITH & NEPHEW, INC. | SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD | 09/12/2006 |
| K061243 | SMITH & NEPHEW, INC. | SMITH & NEPHEW MODULAR FEMORAL HEAD | 07/17/2006 |
| K981451 | STELKAST COMPANY | ARGOMEDICAL BIPOLAR SYSTEM | 08/21/1998 |
| K101356 | TECRES SPA | Spacer-G and Spacer-K | 09/20/2011 |
| K062273 | TECRES SPA | SPACER-G TEMPORARY HIP PROSTHESIS | 05/22/2008 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
