510(k) Report

Devices descending from K212800

2 later devices reach PRIMA Humeral System and SMR Glenosphere Ø42 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+1K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—