510(k) Report

Devices descending from K030710

253 later devices reach Bio-Modular Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+5K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+5K231911Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A.20234—
+5K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+5K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+5K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+5K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.20210—
+5K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+5K202232Comprehensive Vault Reconstruction SystemBiomet Manufacturing Corp20210—
+5K201315PERFORM Humeral System – StemTornier, Inc.2020111
+5K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.20190—
+5K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+5K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+5K163669Humeris ShoulderFx Solutions201720—
+5K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+5K152966Aequalis Fx2Tornier S.A.S.201601
+5K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+5K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S.201429—
+5K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201326—
+5K121220Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/RightExactech, Inc.2012202
+6K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+6K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+6K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+6K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+6K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+6K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+6K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+6K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+6K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+6K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+6K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+6K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+6K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+6K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+6K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+6K181420Aequalis Flex Revive Shoulder SystemTornier, Inc.20184—
+6K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+6K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+6K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+6K150583Aequalis PerFORM+ Shoulder SystemTornier, Inc.201516—
+7K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+7K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)20240—
+7K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+7K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+7K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+7K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+7K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+7K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+7K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+7K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc.20167—
+8K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+8K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+8K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—