510(k) Report

Devices descending from K962224

77 later devices reach Select Shoulder Concentric Humeral Head Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K992525Acumed Modular Shoulder SystemAcu Med, Inc.2000761
+2K130759Humelock II Cementless Shoulder SystemFx Solutions201331—
+2K111097Humelock Cemented Shoulder ProsthesisFx Solutions2011342
+2K101263Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR Shoulder System -…Lima-Lto S.P.A.201138—
+2K100858Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System - Humeral…Lima-Lto S.P.A.2010372
+3K250644MSS - Monobloc stemMedacta International S.A.202611
+3K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+3K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+3K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+3K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+3K161476SMR Shoulder SystemLima Corporate S.P.A.20161—
+3K153722SMR 3-Pegs GlenoidsLima Corporate S.P.A.201613—
+3K150488Humelock II Reversible Shoulder SystemFx Solutions201530—
+3K123814Humelock II Cemented Shoulder SystemFx Solutions201332—
+3K130642SMR 3-Pegs GlenoidsLima Corporate S.P.A.201314—
+3K113254SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone ScrewsLima Corporate S.P.A.201231—
+3K111212SMR Shoulder System- Revision StemsLima Corporate S.P.A.201133—
+3K110847SMR Shoulder System - Cta Humeral HeadsLima Corporate S.P.A.201134—
+4K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+4K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+4K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+4K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG20210—
+4K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+4K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+4K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+4K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+4K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+4K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+4K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+4K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+4K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+4K163669Humeris ShoulderFx Solutions201720—
+4K162455Humelock Reversed ShoulderFx Solutions201717—
+4K143256SMR Modular GlenoidLima Corporate S.P.A.20150—
+4K140071Humelock II Cemented Shoulder SystemFx Solutions201431—
+4K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.201420—
+4K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc.201381
+4K131112Limacorporate SMR Cta Humeral HeadsLima Corporate S.P.A.20130—
+5K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+5K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+5K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+5K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+5K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+5K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+5K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+5K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+5K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+5K211729Comprehensive® Convertible Glenoid - Vivacit-E LinerBiomet Manufacturing Corp20212—
+5K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+5K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+5K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+5K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+5K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.20172—
+6K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+6K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+6K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+6K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+6K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+6K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+6K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+6K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+6K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+6K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+6K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+6K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+6K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+6K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+6K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+7K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+7K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+7K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+7K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+7K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+8K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+8K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+8K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+9K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—