510(k) Report

Devices descending from K011942

111 later devices reach Aequalis Press-Fit Shoulder Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+8K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+8K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+8K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+8K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+8K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+9K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+9K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+10K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+10K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+11K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—