| Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants (K250713) | Exactech, Inc. | 2025-12-01 |
| Tornier Humeral Reconstruction System Max (Tornier HRS Max) (K251686) | Tornier, Inc. | 2025-10-30 |
| AGILON® XO Shoulder Replacement System (K241944) | Implantcast GmbH | 2025-03-10 |
| InSet Total Shoulder System (K241817) | Shoulder Innovations, Inc. | 2025-02-11 |
| AGILON® XO Shoulder Replacement System (K231657) | Implantcast GmbH | 2024-02-16 |
| Comprehensive Segmental Revision System(SRS) (K223631) | Biomet Orthopedics | 2023-07-12 |
| AGILON XO Shoulder System (K222482) | Implantcast GmbH | 2022-09-28 |
| LINK Embrace Shoulder System- Anatomical Configuration (K210899) | Waldemar Link GmbH & Co. KG | 2021-06-21 |
| TiN Coated Humeral Head (K191698) | Fx Shoulder USA, Inc. | 2020-07-16 |
| Shoulder Innovations Total Shoulder System (K192365) | Shoulder Innovations, Inc. | 2019-11-29 |
| Catalyst OrthoScience CSR Shoulder System (K191811) | Catalyst Orthoscience, Inc. | 2019-09-11 |
| Signature ONE System (K190595) | Orthosoft Inc (D/B/A Zimmer Cas) | 2019-06-05 |
| Catalyst CSR Press-Fit Humeral Components (K182500) | Catalyst Orthoscience, Inc. | 2019-01-11 |
| Catalyst CSR Shoulder System (K181287) | Catalyst Orthoscience, Inc. | 2018-07-12 |
| Catalyst CSR 3 Peg Glenoids (K173812) | Catalyst Orthoscience, Inc. | 2018-03-09 |
| Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies (K162903) | Exactech, Inc. | 2017-02-27 |
| SMR Shoulder System (K161476) | Lima Corporate S.P.A. | 2016-06-24 |
| Catalyst CSR Shoulder System (K152825) | Catalyst Orthoscience, LLC | 2016-05-11 |
| Zimmer PSI Shoulder System (K150730) | Zimmer | 2015-06-16 |
| Equinoxe Mega Prosthesis (K143659) | Exactech, Inc. | 2015-04-09 |
| HUMELOCK II CEMENTED SHOULDER SYSTEM (K140071) | Fx Solutions | 2014-07-28 |
| HUMELOCK II CEMENTED SHOULDER SYSTEM (K123814) | Fx Solutions | 2013-08-13 |
| ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, BASE PLATES & HUMERAL STEMS (K121543) | Zimmer, Inc. | 2012-10-11 |
| COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS) (K111746) | Biomet, Inc. | 2011-12-15 |
| BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION (K110791) | Zimmer, Inc. | 2011-09-02 |
| EXACTECH EQUINOXE CUFF TEAR ARTHROPLASTY (CTA) HEAD (K110706) | Exactech, Inc. | 2011-05-17 |
| ANA0TOMICAL SHOULDER TM COMBINED SYSTEM (K103404) | Zimmer GmbH | 2011-03-15 |
| LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL STEMS, LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL BODIES, (K101263) | Lima-Lto S.P.A. | 2011-01-28 |
| LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES, (K100858) | Lima-Lto S.P.A. | 2010-12-10 |
| NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEM (K071147) | Nexa Orthopedics, Inc. | 2007-07-20 |
| ZIMMER TRABECULAR METAL HUMERAL STEM, SIZES 6MM AND 8MM (K050761) | Zimmer, Inc. | 2005-04-11 |
| DISCOVERY-MOSAIC TOTAL HUMERUS SYSTEM (K043505) | Biomet, Inc. | 2005-02-09 |
| MOSAIC NON-MODULAR PROXIMAL BODY AND EAS OFFSET MODULAR HUMERAL HEAD (K042321) | Biomet Manufacturing Corp | 2005-01-28 |
| ZIMMER TRABECULAR METAL HUMERAL STEM (K041549) | Zimmer, Inc. | 2004-09-01 |
| INTERLOK BIO-MODULAR HUMERAL STEMS (K032507) | Biomet, Inc. | 2003-09-05 |
| BIO-MODULAR SHOULDER SYSTEM (K030710) | Biomet, Inc. | 2003-06-04 |
| COMPREHENSIVE HUMERAL FRACTURE SYSTEM (K023063) | Biomet Orthopedics, Inc. | 2002-12-13 |
| THE TRABECULAR METAL GLENOID-BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4306 (K022377) | Implex Corp. | 2002-12-10 |
| SHORT AND LONG SOFT TISSUE ATTACHMENT (K022079) | Biomet, Inc. | 2002-09-24 |
| 3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM (K020045) | Biomet Orthopedics, Inc. | 2002-01-30 |
| EPOCA CODR STEM AND HEAD (K014049) | Stelkast Company | 2002-01-09 |
| EPOCA CUSTOM OFFSET SHOULDER SYSTEM (K010869) | Argomedical AG | 2001-10-11 |
| BIOMET BI-POLAR SHOULDER SYSTEM (K002998) | Biomet, Inc. | 2000-10-06 |
| BIPOLAR SHOULDER PROSTHESIS (K991585) | Biomet, Inc. | 1999-08-18 |
| GRIT BLASTED HUMERAL STEM (K991603) | Encore Orthopedics, Inc. | 1999-06-29 |
| GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEAD (K984541) | DePuy Orthopaedics, Inc. | 1999-01-14 |
| NEW ZIMMER SHOULDER SYSTEM (K982981) | Zimmer, Inc. | 1998-12-17 |
| SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS (K970567) | Intermedics Orthopedics | 1997-02-27 |
| SELECT SHOULDER COCR HUMERAL STEM COMPONENT (K962315) | Intermedics Orthopedics | 1996-09-03 |
| BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD (K960424) | Endotec, Inc. | 1996-08-26 |
| SELECT SHOULDER KEELED ALL-POLY GLENOIDS (K962238) | Intermedics Orthopedics | 1996-08-09 |
| SELECT SHOULDER PEGGED ALL-POLY GLENOID (K962244) | Intermedics Orthopedics | 1996-08-09 |
| COCR BI-ANGULAR HUMERAL COMPONENT (K961571) | Biomet, Inc. | 1996-08-05 |
| KIRSCHNER(R) MODULAR II-C(TM) TOTAL SHOULDER SYSTEM (K940537) | Kirschner Medical Corp. | 1995-08-29 |
| PROXIMAL HUMERAL REPLACEMENT SYSTEM (K925613) | Biomet, Inc. | 1994-10-14 |
| SELECT(R) SHOULDER ALL-POLY GLENOID (K931114) | Intermedics Orthopedics | 1994-05-09 |
| NEER TYPE SHOULDER PROSTHESIS SYSTEM (K922865) | Osteo Technology, Inc. | 1992-12-10 |
| BIOMODULAR SHOULDER HUMERAL HEAD W/ IONGUARD (K915596) | Biomet, Inc. | 1992-03-11 |
| GLOBAL TOTAL SHOULDER (K914695) | Depuy, Inc. | 1992-01-16 |
| GLOBAL(TM) TOTAL SHOULDER W/DUPONT ENHANCED UHMWPE (K914000) | Depuy, Inc. | 1991-12-04 |
| GLOBAL TOTAL SHOULDER (K905786) | Depuy, Inc. | 1991-03-26 |
| NON CONSTRAINED TOTAL SHOULDER SYSTEM (K895802) | Orthopaedic Medical Group, Inc. | 1989-12-27 |
| NEER-III OSTEOARTHRITIS GLENOID RESURFACE PROSTHE. (K873620) | Kirschner Medical Corp. | 1987-10-15 |
| NEER-III GLENOID RESURFACING PROSTHESIS (K873104) | Kirschner Medical Corp. | 1987-10-15 |
| NEER-III SOLID KEEL GLENOID RESURFACING PROSTHESIS (K873621) | Kirschner Medical Corp. | 1987-10-15 |
| BIOMET MODULAR SHOULDER PROSTHESIS (K872454) | Biomet, Inc. | 1987-08-27 |
| MONOSPHERICAL RESURFACING GLENOID PROS (K833409) | Howmedica Corp. | 1983-11-07 |
| GLENOID RESURFACING COMPONENT-3M-10816 (K831233) | 3M Company | 1983-06-03 |
| GLENOID RESURFACE COMPONENT PMN 3M (K831234) | 3M Company | 1983-06-02 |
| GRISTINA GLENOID PROSTHESIS (K802124) | Howmedica Corp. | 1980-12-01 |
| ZIMMER R TOTAL SHOULDER II (K790987) | Zimmer, Inc. | 1979-06-22 |