Panels › Orthopedic › Product code KWT · Class 2
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Regulation 888.3650
2510(k)s in 12 months (72 all time)
0recalls in 12 months (31 all time)
28recalls that name a 510(k)
Top companies in KWT
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer | 8 | 16 |
| Biomet, Inc. | 11 | 4 |
| Exactech, Inc. | 4 | 5 |
| Catalyst Orthoscience, Inc. | 5 | 0 |
| Intermedics Orthopedics | 5 | 0 |
| Zimmer Biomet, Inc. | 0 | 5 |
| Kirschner Medical Corp. | 4 | 0 |
| Biomet Orthopedics | 3 | 0 |
| Depuy, Inc. | 3 | 0 |
| Implantcast GmbH | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 8, 2026 | K262173 | N22 Offset Humeral Head Shoulder Innovations, Inc. | KWT |
| Dec 1, 2025 | K250713 | Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants Exactech, Inc. | KWT |
| Oct 30, 2025 | K251686 | Tornier Humeral Reconstruction System Max (Tornier HRS Max) Tornier, Inc. | KWT |
| Mar 10, 2025 | K241944 | AGILON® XO Shoulder Replacement System Implantcast GmbH, DE | KWT |
| Feb 11, 2025 | K241817 | InSet Total Shoulder System Shoulder Innovations, Inc. | KWT |
| Feb 16, 2024 | K231657 | AGILON® XO Shoulder Replacement System Implantcast GmbH, DE | KWT |
| Jul 12, 2023 | K223631 | Comprehensive Segmental Revision System(SRS) Biomet Orthopedics | KWT |
| Sep 28, 2022 | K222482 | AGILON XO Shoulder System Implantcast GmbH, DE | KWT |
| Jun 21, 2021 | K210899 | LINK Embrace Shoulder System- Anatomical Configuration Waldemar Link GmbH & Co. KG, DE | KWT |
| Jul 16, 2020 | K191698 | TiN Coated Humeral Head Fx Shoulder USA, Inc. | KWT |
| Nov 29, 2019 | K192365 | Shoulder Innovations Total Shoulder System Shoulder Innovations, Inc. | KWT |
| Sep 11, 2019 | K191811 | Catalyst OrthoScience CSR Shoulder System Catalyst Orthoscience, Inc. | KWT |
| Jun 5, 2019 | K190595 | Signature ONE System Orthosoft Inc (D/B/A Zimmer Cas), CA | KWT |
| Jan 11, 2019 | K182500 | Catalyst CSR Press-Fit Humeral Components Catalyst Orthoscience, Inc. | KWT |
| Jul 12, 2018 | K181287 | Catalyst CSR Shoulder System Catalyst Orthoscience, Inc. | KWT |
| Mar 9, 2018 | K173812 | Catalyst CSR 3 Peg Glenoids Catalyst Orthoscience, Inc. | KWT |
| Feb 27, 2017 | K162903 | Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies Exactech, Inc. | KWT |
| Jun 24, 2016 | K161476 | SMR Shoulder System Lima Corporate S.P.A., IT | KWT |
| May 11, 2016 | K152825 | Catalyst CSR Shoulder System Catalyst Orthoscience, LLC | KWT |
| Jun 16, 2015 | K150730 | Zimmer PSI Shoulder System Zimmer, CA | KWT |
| Apr 9, 2015 | K143659 | Equinoxe Mega Prosthesis Exactech, Inc. | KWT |
| Jul 28, 2014 | K140071 | HUMELOCK II CEMENTED SHOULDER SYSTEM Fx Solutions, FR | KWT |
| Aug 13, 2013 | K123814 | HUMELOCK II CEMENTED SHOULDER SYSTEM Fx Solutions, FR | KWT |
| Oct 11, 2012 | K121543 | ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, BASE PLATES & HUMERAL STEMS Zimmer, Inc. | KWT |
| Dec 15, 2011 | K111746 | COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS) Biomet, Inc. | KWT |
| Sep 2, 2011 | K110791 | BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION Zimmer, Inc. | KWT |
| May 17, 2011 | K110706 | EXACTECH EQUINOXE CUFF TEAR ARTHROPLASTY (CTA) HEAD Exactech, Inc. | KWT |
| Mar 15, 2011 | K103404 | ANA0TOMICAL SHOULDER TM COMBINED SYSTEM Zimmer GmbH | KWT |
| Jan 28, 2011 | K101263 | LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL STEMS, LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL BODIES, Lima-Lto S.P.A. | KWT |
| Dec 10, 2010 | K100858 | LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES, Lima-Lto S.P.A. | KWT |
| Jul 20, 2007 | K071147 | NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEM Nexa Orthopedics, Inc. | KWT |
| Apr 11, 2005 | K050761 | ZIMMER TRABECULAR METAL HUMERAL STEM, SIZES 6MM AND 8MM Zimmer, Inc. | KWT |
| Feb 9, 2005 | K043505 | DISCOVERY-MOSAIC TOTAL HUMERUS SYSTEM Biomet, Inc. | KWT |
| Jan 28, 2005 | K042321 | MOSAIC NON-MODULAR PROXIMAL BODY AND EAS OFFSET MODULAR HUMERAL HEAD Biomet Manufacturing Corp | KWT |
| Sep 1, 2004 | K041549 | ZIMMER TRABECULAR METAL HUMERAL STEM Zimmer, Inc. | KWT |
| Sep 5, 2003 | K032507 | INTERLOK BIO-MODULAR HUMERAL STEMS Biomet, Inc. | KWT |
| Jun 4, 2003 | K030710 | BIO-MODULAR SHOULDER SYSTEM Biomet, Inc. | KWT |
| Dec 13, 2002 | K023063 | COMPREHENSIVE HUMERAL FRACTURE SYSTEM Biomet Orthopedics, Inc. | KWT |
| Dec 10, 2002 | K022377 | THE TRABECULAR METAL GLENOID-BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4306 Implex Corp. | KWT |
| Sep 24, 2002 | K022079 | SHORT AND LONG SOFT TISSUE ATTACHMENT Biomet, Inc. | KWT |
| Jan 30, 2002 | K020045 | 3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM Biomet Orthopedics, Inc. | KWT |
| Jan 9, 2002 | K014049 | EPOCA CODR STEM AND HEAD Stelkast Company | KWT |
| Oct 11, 2001 | K010869 | EPOCA CUSTOM OFFSET SHOULDER SYSTEM Argomedical AG | KWT |
| Oct 6, 2000 | K002998 | BIOMET BI-POLAR SHOULDER SYSTEM Biomet, Inc. | KWT |
| Aug 18, 1999 | K991585 | BIPOLAR SHOULDER PROSTHESIS Biomet, Inc. | KWT |
| Jun 29, 1999 | K991603 | GRIT BLASTED HUMERAL STEM Encore Orthopedics, Inc. | KWT |
| Jan 14, 1999 | K984541 | GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEAD DePuy Orthopaedics, Inc. | KWT |
| Dec 17, 1998 | K982981 | NEW ZIMMER SHOULDER SYSTEM Zimmer, Inc. | KWT |
| Feb 27, 1997 | K970567 | SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS Intermedics Orthopedics | KWT |
| Sep 3, 1996 | K962315 | SELECT SHOULDER COCR HUMERAL STEM COMPONENT Intermedics Orthopedics | KWT |
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