FDA 510(k) Applications for Medical Device Product Code "KWT"
(Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K010869 | ARGOMEDICAL AG | EPOCA CUSTOM OFFSET SHOULDER SYSTEM | 10/11/2001 |
| K042321 | BIOMET MANUFACTURING CORP. | MOSAIC NON-MODULAR PROXIMAL BODY AND EAS OFFSET MODULAR HUMERAL HEAD | 01/28/2005 |
| K223631 | Biomet Orthopedics | Comprehensive Segmental Revision System(SRS) | 07/12/2023 |
| K020045 | BIOMET ORTHOPEDICS, INC. | 3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM | 01/30/2002 |
| K023063 | BIOMET ORTHOPEDICS, INC. | COMPREHENSIVE HUMERAL FRACTURE SYSTEM | 12/13/2002 |
| K030710 | BIOMET, INC. | BIO-MODULAR SHOULDER SYSTEM | 06/04/2003 |
| K002998 | BIOMET, INC. | BIOMET BI-POLAR SHOULDER SYSTEM | 10/06/2000 |
| K991585 | BIOMET, INC. | BIPOLAR SHOULDER PROSTHESIS | 08/18/1999 |
| K961571 | BIOMET, INC. | COCR BI-ANGULAR HUMERAL COMPONENT | 08/05/1996 |
| K111746 | BIOMET, INC. | COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS) | 12/15/2011 |
| K043505 | BIOMET, INC. | DISCOVERY-MOSAIC TOTAL HUMERUS SYSTEM | 02/09/2005 |
| K032507 | BIOMET, INC. | INTERLOK BIO-MODULAR HUMERAL STEMS | 09/05/2003 |
| K022079 | BIOMET, INC. | SHORT AND LONG SOFT TISSUE ATTACHMENT | 09/24/2002 |
| K152825 | CATALYST ORTHOSCIENCE LLC | Catalyst CSR Shoulder System | 05/11/2016 |
| K173812 | Catalyst OrthoScience, Inc | Catalyst CSR 3 Peg Glenoids | 03/09/2018 |
| K182500 | Catalyst OrthoScience, Inc. | Catalyst CSR Press-Fit Humeral Components | 01/11/2019 |
| K181287 | Catalyst OrthoScience, Inc. | Catalyst CSR Shoulder System | 07/12/2018 |
| K191811 | Catalyst OrthoScience, Inc. | Catalyst OrthoScience CSR Shoulder System | 09/11/2019 |
| K984541 | DEPUY ORTHOPAEDICS, INC. | GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEAD | 01/14/1999 |
| K991603 | ENCORE ORTHOPEDICS, INC. | GRIT BLASTED HUMERAL STEM | 06/29/1999 |
| K960424 | ENDOTEC, INC. | BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD | 08/26/1996 |
| K162903 | Exactech Inc | Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies | 02/27/2017 |
| K143659 | EXACTECH, INC. | Equinoxe Mega Prosthesis | 04/09/2015 |
| K110706 | EXACTECH, INC. | EXACTECH EQUINOXE CUFF TEAR ARTHROPLASTY (CTA) HEAD | 05/17/2011 |
| K191698 | FX Shoulder USA, Inc. | TiN Coated Humeral Head | 07/16/2020 |
| K123814 | FX SOLUTIONS | HUMELOCK II CEMENTED SHOULDER SYSTEM | 08/13/2013 |
| K140071 | FX SOLUTIONS | HUMELOCK II CEMENTED SHOULDER SYSTEM | 07/28/2014 |
| K222482 | implantcast, GmbH | AGILON XO Shoulder System | 09/28/2022 |
| K241944 | implantcast, GmbH | AGILON« XO Shoulder Replacement System | 03/10/2025 |
| K231657 | Implantcast, GmbH | AGILON« XO Shoulder Replacement System | 02/16/2024 |
| K022377 | IMPLEX CORP. | THE TRABECULAR METAL GLENOID-BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4306 | 12/10/2002 |
| K962315 | INTERMEDICS ORTHOPEDICS | SELECT SHOULDER COCR HUMERAL STEM COMPONENT | 09/03/1996 |
| K970567 | INTERMEDICS ORTHOPEDICS | SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS | 02/27/1997 |
| K962238 | INTERMEDICS ORTHOPEDICS | SELECT SHOULDER KEELED ALL-POLY GLENOIDS | 08/09/1996 |
| K962244 | INTERMEDICS ORTHOPEDICS | SELECT SHOULDER PEGGED ALL-POLY GLENOID | 08/09/1996 |
| K100858 | LIMA-LTO S.P.A. | LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES, | 12/10/2010 |
| K101263 | LIMA-LTO S.P.A. | LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL STEMS, LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL BODIES, | 01/28/2011 |
| K161476 | Limacorporate S.p.A. | SMR Shoulder System | 06/24/2016 |
| K071147 | NEXA ORTHOPEDICS, INC. | NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEM | 07/20/2007 |
| K190595 | Orthosoft Inc. (d/b/a Zimmer CAS) | Signature ONE System | 06/05/2019 |
| K192365 | Shoulder Innovations Inc | Shoulder Innovations Total Shoulder System | 11/29/2019 |
| K241817 | Shoulder Innovations, Inc. | InSet Total Shoulder System | 02/11/2025 |
| K014049 | STELKAST COMPANY | EPOCA CODR STEM AND HEAD | 01/09/2002 |
| K210899 | Waldemar Link GmbH & Co. KG | LINK Embrace Shoulder System- Anatomical Configuration | 06/21/2021 |
| K150730 | ZIMMER | Zimmer PSI Shoulder System | 06/16/2015 |
| K103404 | ZIMMER GMBH | ANA0TOMICAL SHOULDER TM COMBINED SYSTEM | 03/15/2011 |
| K110791 | ZIMMER, INC. | BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION | 09/02/2011 |
| K982981 | ZIMMER, INC. | NEW ZIMMER SHOULDER SYSTEM | 12/17/1998 |
| K041549 | ZIMMER, INC. | ZIMMER TRABECULAR METAL HUMERAL STEM | 09/01/2004 |
| K050761 | ZIMMER, INC. | ZIMMER TRABECULAR METAL HUMERAL STEM, SIZES 6MM AND 8MM | 04/11/2005 |
| K121543 | ZIMMER, INC. | ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, BASE PLATES & HUMERAL STEMS | 10/11/2012 |
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