510(k) Report

Devices descending from K163397

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+1K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+1K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+1K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+2K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+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—