510(k) Report

Devices descending from K952928

393 later devices reach Aequalis Shoulder System for Total & Hemishoulder Applications through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+4K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+4K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+4K240876Identity Shoulder SystemZimmer, Inc.20241—
+4K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+4K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+4K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+4K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+4K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+4K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+4K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+4K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+4K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+4K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+4K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc.20230—
+4K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+4K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+4K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+4K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+4K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+4K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+4K212356Exactech® Equinoxe® Laser Cage GlenoidExactech, Inc.202221
+4K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+4K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+4K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+4K211729Comprehensive® Convertible Glenoid - Vivacit-E LinerBiomet Manufacturing Corp20212—
+4K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+4K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+4K210533Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20213—
+4K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.20210—
+4K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+4K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+4K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG20210—
+4K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+4K210167DELTA XTEND Reverse Shoulder SystemDePuy Orthopaedics, Inc.20210—
+4K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+4K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+4K193038Comprehensive Shoulder SystemBiomet Manufacturing Corp202081
+4K201315PERFORM Humeral System – StemTornier, Inc.2020111
+4K192097Exactech® Equinoxe® Stemless Humeral ComponentsExactech, Inc.20201—
+4K193373Comprehensive® Reverse ShoulderBiomet, Inc.2020202
+4K192967Medacta Shoulder SystemMedacta International S.A.20200—
+4K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland)20203—
+4K193180Alliance Augmented GlenoidZimmer, Inc.20203—
+4K193099Anatomical Shoulder SystemZimmer GmbH20201—
+4K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+4K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+4K192448Delta Xtend Revers Shoulder SystemDepuy (Ireland)20191—
+4K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.20190—
+4K191393INFINITY Total Ankle System, INBONE Total Ankle SystemWrightmedicaltechnologyinc20190—
+4K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+4K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp20196—
+4K181555Arthrex Fracture Adapter Hemi Shoulder ProsthesisArthrex, Inc.20181—
+4K173824Humeral Short Stem SystemShoulder Innovations, Inc.20183—
+4K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+4K181611Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp201810—
+4K181557INFINITY Total Ankle SystemWrightmedicaltechnologyinc20180—
+4K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+4K173900Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.201817—
+4K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+4K171841Arthrex Shoulder SystemArthrex, Inc.20181—
+4K172371Arthrex UNIVERS REVERS COATED BASEPLATEArthrex, Inc.20183—
+4K173411Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp20182—
+4K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp2018201
+4K172767Zimmer Trabecular Metal Reverse Shoulder System, Mini GlenoidZimmer, Inc.20170—
+4K163669Humeris ShoulderFx Solutions201720—
+4K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+4K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+4K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.20164—
+4K161620Anatomical Shoulder Domelock Dome centricZimmer GmbH20163—
+4K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+4K153398Comprehensive SRS/Nexel ElbowBiomet Manufacturing Corp20163—
+4K152267Remedy® Shoulder SpacerOsteoremedies, LLC20152—
+4K143659Equinoxe Mega ProsthesisExactech, Inc.20155—
+4K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie20155—
+4K140652Porous Coated Comprehensive Fracture StemsBiomet Manufacturing Corp20140—
+4K141006RSP Humeral Socket InsertDjo Global2014212
+4K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P.201455—
+4K133462Duocentric Reversed Shoulder ProsthesisAston Medical20140—
+4K131135Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet Manufacturing Corp201445
+4K130048Reverse Shoulder Prosthesis MonoblockEncore Medical L.P.201359—
+4K132435Smith & Nephew Global Femoral Head TrialsSmith & Nephew, Inc.20130—
+4K131633Arthrex Univers ApexArthrex, Inc.20134—
+4K132239Comprehensive Reverse Shoulder ScrewsBiomet Manufacturing Corp2013252
+4K131575Exactech Equinox Superior/Posterior Augment Reverse Shoulder Glenoid Baseplate - Left &…Exactech, Inc.20136—
+4K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+4K121183Comprehensive Reverse Shoulder - E1 Polyethylene ClaimsBiomet Corporation201214—
+4K112900SMR Resurfacing Shoulder System- Humeral Heads, Cta Humeral HeadsLima Corporate S.P.A.20120—
+4K120794Ascend Shoulder SystemTornier, Inc.201298—
+4K120121Comprehensive Reverse Shoulder-Mini BaseplateBiomet, Inc.2012694
+4K113069Comprehensive Reverse Shoulder Humeral TrayBiomet Manufacturing Corp201235—
+4K113523Limacorporate SMR Reverse Shoulder SystemLima Corporate S.P.A.201110—
+4K113121Comprehensive Reverse ShoulderBiomet Manufacturing, Inc.201131—
+4K112983Spacer-STecres S.P.A.20117—
+4K111379Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Exactech, Inc.2011212
+4K093803Bio-Modular Reverse SholderBiomet Manufacturing Corp201061—
+4K091196GRS Glenoid Resurfacing SystemArthrosurface, Inc.200923—
+4K080990Depuy Global C.AP. Cta Resurfacing ShoulderDePuy Orthopaedics, Inc.20082—
+4K071064Ascension Humeral Resurfacing Arthoplasty (Hra) System TPS/HAAscension Orthopedics, Inc.20070—
+4K062861Ascension Humeral Resurfacing Arthroplasty SystemAscension Orthopedics, Inc.200621