510(k) Report

Devices descending from K191746

12 later devices reach SMR TT Augmented Glenoid System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+1K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+2K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+2K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+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—
+3K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+3K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+4K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+4K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+4K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+5K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—