510(k) Report

Devices descending from K950594

20 later devices reach Hemi-Shoulder Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+2K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+2K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+2K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+3K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+3K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+3K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+3K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+3K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+3K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+3K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+3K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+3K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+3K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+3K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+4K254003JARVIS Metaphyseal StemFH Industrie20260—
+4K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+4K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+4K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+4K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—