510(k) Report

Devices descending from K063578

67 later devices reach Promos Modular Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121714Smith & Nephew, Inc. Shoulder System InstrumentsSmith & Nephew, Inc.20120—
+1K113012Promos Modular Shoulder SystemSmith & Nephew, Inc.20120—
+1K101263Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR Shoulder System -…Lima-Lto S.P.A.201138—
+1K100858Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System - Humeral…Lima-Lto S.P.A.2010372
+1K100448Ascension Modular Total Shoulder SystemAscension Orthopedics, Inc.201051
+1K081016Smith & Nephew, Inc., Promos Reverse Shoulder SystemSmith & Nephew, Inc.2008522
+2K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+2K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+2K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+2K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+2K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+2K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+2K161476SMR Shoulder SystemLima Corporate S.P.A.20161—
+2K153722SMR 3-Pegs GlenoidsLima Corporate S.P.A.201613—
+2K152047INTEGRA TITAN Modular Total Shoulder System Fin-Lock GlenoidAscension Orthopedics20151—
+2K142139SMR 40MM GlenosphereLima Corporate S.P.A.201413—
+2K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+2K130642SMR 3-Pegs GlenoidsLima Corporate S.P.A.201314—
+2K113039Smith & Nephew Radiopaque Trial NecksSmith & Nephew, Inc.20121—
+2K112438Titan Modular Total Shoulder SystemAscension Orthopedic20123—
+2K113254SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone ScrewsLima Corporate S.P.A.201231—
+2K110598SMR Reverse Shoulder SystemLima Corporate S.P.A.2011441
+2K111212SMR Shoulder System- Revision StemsLima Corporate S.P.A.201133—
+2K110847SMR Shoulder System - Cta Humeral HeadsLima Corporate S.P.A.201134—
+3K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+3K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+3K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+3K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+3K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+3K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+3K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+3K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG20210—
+3K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+3K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+3K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+3K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+3K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+3K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+3K143256SMR Modular GlenoidLima Corporate S.P.A.20150—
+3K142413TITAN Modular Total Shoulder SystemAscension Orthopedics20142—
+3K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.201420—
+3K132435Smith & Nephew Global Femoral Head TrialsSmith & Nephew, Inc.20130—
+3K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc.201381
+3K131112Limacorporate SMR Cta Humeral HeadsLima Corporate S.P.A.20130—
+3K113523Limacorporate SMR Reverse Shoulder SystemLima Corporate S.P.A.201110—
+4K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+4K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+4K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+4K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+4K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+4K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+4K211729Comprehensive® Convertible Glenoid - Vivacit-E LinerBiomet Manufacturing Corp20212—
+4K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+4K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+4K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+4K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+4K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.20172—
+5K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+5K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+5K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+5K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+5K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+6K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+6K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+6K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+6K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+7K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—