510(k) Report

Devices descending from K060704

207 later devices reach Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+8K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+8K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+8K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+8K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+9K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+9K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—