PRIMA Humeral System and SMR Glenosphere Ø42

K212800 is the FDA 510(k) clearance record for PRIMA Humeral System and SMR Glenosphere Ø42, a class II device, cleared for Lima Corporate S.P.A. on 2022-02-25 under FDA product code PHX (Shoulder Prosthesis, Reverse Configuration). FDA's definition for product code PHX reads: "Intended to be used to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a...". FDA records list 64 510(k) clearances for Lima Corporate S.P.A., from 2011-07-15 to 2026-01-22. As of 2026-09-10, FDA records show 2 recalls naming K212800.