510(k) Report

Devices descending from K042377

17 later devices reach Synthes Low Profile Reconstruction Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221809DePuy Synthes 3.5mm Intrapelvic Acetabular SystemDePuy Synthes20222—
+1K201229Intai Anatomic Locking Plate and Screw SystemIntai Technology Corporation20220—
+1K200295IlluminOss Bone Stabilization SystemIlluminoss Medical, Inc.20200—
+1K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+1K142836Zimmer Plates and Screws (ZPS), Forte ScrewsZimmer, Inc.20145—
+1K051155Solco 4CIS General Plate SystemSolco Biomedical Co., Ltd.20050—
+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—
+2K143331Zimmer Plates and Screws System (ZPS) - Non-sterile ZPSZimmer, Inc.20154—
+3K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+3K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+3K152841Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical ScrewsZimmer, Inc.20150—
+4K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+4K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—