510(k) Report

Devices descending from K172502

20 later devices reach Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+1K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+1K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+1K210533Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20213—
+1K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+1K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+2K252516N22 EZ GlenosphereShoulder Innovations, Inc.20260—
+2K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+2K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+2K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+3K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+3K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+3K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+4K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+4K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+4K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+5K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+5K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+5K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+6K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—