510(k) Report

Devices descending from K003801

365 later devices reach Anatomical Press-Fit Humeral Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042021Exactech Equinoxe Shoulder SystemExactech, Inc.20047110
+1K032126Promos ShoulderPlus Orthopedics2004130—
+1K030259Amatomical Shoulder with Removable HeadCenterplus Orthopedics, Inc.20033313
+2K173388Exactech Equinoxe Stemless ShoulderExactech, Inc.20189—
+2K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined SystemZimmer GmbH20172—
+2K162726Exactech® Equinoxe® Preserve StemExactech, Inc.201731
+2K160085Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder…Zimmer GmbH20163—
+2K150568ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie20154—
+2K142403Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder…Zimmer GmbH201451
+2K140063Equinoxe Extra Short Humeral HeadExactech, Inc.201410—
+2K121067Exactech Equinoxe Shoulder System Torque Defining Screw and Short Replicator PlateExactech, Inc.20120—
+2K121714Smith & Nephew, Inc. Shoulder System InstrumentsSmith & Nephew, Inc.20120—
+2K113309Exactech Equinoxe Cage GlenoidsExactech, Inc.201138
+2K110706Exactech Equinoxe Cuff Tear Arthroplasty (Cta) HeadExactech, Inc.20110—
+2K103404ANA0TOMICAL Shoulder TM Combined SystemZimmer GmbH201131
+2K101263Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR Shoulder System -…Lima-Lto S.P.A.201138—
+2K103419Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc.2010222
+2K100858Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System - Humeral…Lima-Lto S.P.A.2010372
+2K093599Arrow Anatomical Shoulder SystemFournitures Hospitalieres Industrie201011—
+2K102951Exactech Equinox Fixed Angle Replicator Plate (0MM,1.5MM,4.5MM), Humeral Head-Short…Exactech, Inc.201072
+2K093430Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid…Exactech, Inc.2010241
+2K100448Ascension Modular Total Shoulder SystemAscension Orthopedics, Inc.201051
+2K092900Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture StemExactech, Inc.201022
+2K063578Promos Modular Shoulder SystemPlus Orthopedics AG2007674
+2K062029Anatomical Shoulder Fracture SystemZimmer GmbH2006103
+2K060874Depuy Global AP Shoulder SystemDePuy Orthopaedics, Inc.2006200—
+2K061454Exactech Equinoxe Shoulder StemsExactech, Inc.200616—
+2K060535Spacer-S Temporary Shoulder SpacerTecres S.P.A.20068—
+2K053274Anatomical Shoulder Inverse/ReverseZimmer GmbH20062393
+3K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.20250—
+3K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+3K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+3K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+3K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+3K212356Exactech® Equinoxe® Laser Cage GlenoidExactech, Inc.202221
+3K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+3K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+3K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+3K203230Global Shoulder and Delta CTA systemsDepuy Lnc.20210—
+3K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+3K192097Exactech® Equinoxe® Stemless Humeral ComponentsExactech, Inc.20201—
+3K193099Anatomical Shoulder SystemZimmer GmbH20201—
+3K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+3K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp20196—
+3K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+3K180632Exactech Equinoxe Small Reverse Shoulder SystemExactech, Inc.201853
+3K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie20174—
+3K161620Anatomical Shoulder Domelock Dome centricZimmer GmbH20163—
+3K161476SMR Shoulder SystemLima Corporate S.P.A.20161—
+3K153722SMR 3-Pegs GlenoidsLima Corporate S.P.A.201613—
+3K152047INTEGRA TITAN Modular Total Shoulder System Fin-Lock GlenoidAscension Orthopedics20151—
+3K152267Remedy® Shoulder SpacerOsteoremedies, LLC20152—
+3K150488Humelock II Reversible Shoulder SystemFx Solutions201530—
+3K142863Univers Rivers Shoulder Prosthesis SystemArthrex, Inc.201427—
+3K142139SMR 40MM GlenosphereLima Corporate S.P.A.201413—
+3K130759Humelock II Cementless Shoulder SystemFx Solutions201331—
+3K131277Seviin Fracture ShoulderIngen Orthopedics, LLC20130—
+3K123814Humelock II Cemented Shoulder SystemFx Solutions201332—
+3K130642SMR 3-Pegs GlenoidsLima Corporate S.P.A.201314—
+3K130129Univers Revers Shoulder Prosthesis SystemArthrex, Inc.201328—
+3K123122Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Cleveland Clinic201356—
+3K112193Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie201210—
+3K120374Seviin Reverse ShoulderIngen Orthopedics, LLC20121—
+3K112438Titan Modular Total Shoulder SystemAscension Orthopedic20123—
+3K113254SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone ScrewsLima Corporate S.P.A.201231—
+3K113012Promos Modular Shoulder SystemSmith & Nephew, Inc.20120—
+3K112983Spacer-STecres S.P.A.20117—
+3K103251Duocentric ReversedAston Medical20117—
+3K110598SMR Reverse Shoulder SystemLima Corporate S.P.A.2011441
+3K111212SMR Shoulder System- Revision StemsLima Corporate S.P.A.201133—
+3K110847SMR Shoulder System - Cta Humeral HeadsLima Corporate S.P.A.201134—
+3K111379Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Exactech, Inc.2011212
+3K101996Depuy Global Unite Shoulder SystemDepuy (Ireland)2010168
+3K101909Exactech Equinoxe, Platform Fracture StemExactech, Inc.201004
+3K081016Smith & Nephew, Inc., Promos Reverse Shoulder SystemSmith & Nephew, Inc.2008522
+3K080642Comprehensive Reverse ShoulderBiomet, Inc.2008172Class I
+3K071948Aequalis Reversed AdapterTornier2007178—
+3K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200719013
+3K063652Global AP Porous Coated Humeral StemDePuy Orthopaedics, Inc.200718—
+3K063081Aequalis Shoulder SystemTornier2006162—
+4K260556Veritas Shoulder SystemRestor3D20260—
+4K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+4K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+4K250644MSS - Monobloc stemMedacta International S.A.202611
+4K254003JARVIS Metaphyseal StemFH Industrie20260—
+4K252443SpaceFix Shoulder SpacerG21, S.R.L.20250—
+4K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+4K241470CORE Shoulder SystemLinkBio Corp.202501
+4K243248Inhance Intact™Depuy Ireland UC20240—
+4K241873OsseoFit Stemless Shoulder SystemZimmer, Inc.20241—
+4K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+4K240856Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsOsartis GmbH20240—
+4K233482Equinoxe® Central Screw Baseplate SystemExactech, Inc.20240—
+4K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+4K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+4K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+4K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+4K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+4K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc.20230—
+4K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—