510(k) Report

Devices descending from K190911

8 later devices reach Physica KR Liner and SMR Reverse Humeral Liner through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+2K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+2K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+2K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+3K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+3K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+3K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+4K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—