510(k) Report

Devices descending from K081448

32 later devices reach Encore Shoulder Revision Glenoid through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113254SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone ScrewsLima Corporate S.P.A.201231—
+2K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+2K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+2K153722SMR 3-Pegs GlenoidsLima Corporate S.P.A.201613—
+2K143256SMR Modular GlenoidLima Corporate S.P.A.20150—
+2K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.201420—
+2K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc.201381
+3K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+3K211729Comprehensive® Convertible Glenoid - Vivacit-E LinerBiomet Manufacturing Corp20212—
+3K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+3K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+3K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+3K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.20172—
+4K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+4K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+4K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+4K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+4K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+4K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG20210—
+4K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+4K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+5K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+5K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+5K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+6K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+6K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+6K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+6K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+7K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+7K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+7K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+8K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—