510(k) Report

Devices descending from K081620

109 later devices reach Modification to Depuy Delta Xtend Reverse Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+7K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+7K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+7K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+8K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+8K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+9K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+9K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+10K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—