510(k) Report

Devices descending from K202716

13 later devices reach Ignite Anatomic Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+1K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+1K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+1K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+1K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+2K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+2K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+2K250644MSS - Monobloc stemMedacta International S.A.202611
+2K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+2K243248Inhance Intact™Depuy Ireland UC20240—
+2K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+3K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+3K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—