510(k) Report

Devices descending from K172351

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