510(k) Report

Devices descending from K071147

120 later devices reach Nexa Orthopedics Total Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+7K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+7K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+7K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+7K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+7K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+7K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+7K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+8K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+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—