510(k) Report

Devices descending from K002998

265 later devices reach Biomet BI-Polar Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+5K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+5K131277Seviin Fracture ShoulderIngen Orthopedics, LLC20130—
+5K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+5K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+5K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+5K111379Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Exactech, Inc.2011212
+5K101909Exactech Equinoxe, Platform Fracture StemExactech, Inc.201004
+6K260556Veritas Shoulder SystemRestor3D20260—
+6K261683Augment Off-Axis Instrument SystemZimmer, Inc.20260—
+6K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+6K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+6K252443SpaceFix Shoulder SpacerG21, S.R.L.20250—
+6K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+6K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+6K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+6K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+6K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+6K231911Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A.20234—
+6K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+6K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+6K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.20210—
+6K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+6K202232Comprehensive Vault Reconstruction SystemBiomet Manufacturing Corp20210—
+6K201315PERFORM Humeral System – StemTornier, Inc.2020111
+6K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+6K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+6K163669Humeris ShoulderFx Solutions201720—
+6K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+6K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+6K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S.201429—
+6K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201326—
+6K121220Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/RightExactech, Inc.2012202
+7K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+7K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+7K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+7K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+7K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+7K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+7K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+7K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+7K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+7K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+7K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+7K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+7K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+7K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+7K181420Aequalis Flex Revive Shoulder SystemTornier, Inc.20184—
+7K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+7K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+7K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+7K150583Aequalis PerFORM+ Shoulder SystemTornier, Inc.201516—
+8K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+8K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)20240—
+8K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+8K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+8K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+8K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+8K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+8K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+8K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+8K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc.20167—
+9K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+9K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+9K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—