510(k) Report

Devices descending from K061973

9 later devices reach Synthes 3.5MM Spring Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+1K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+2K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+2K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+2K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+2K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+2K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+2K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+3K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—