510(k) Report

Devices descending from K083694

29 later devices reach Synthes (Usa) 2.4 MM VA-LCP Two Column Volar Distal Radius Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252959WRISTAR MultiAx Distal Radius KitIntrauma S.P.A20250—
+1K243469SignexOsteonic Co., Ltd.20250—
+1K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+1K232394Internal Locking Plate and Screw Fixation SystemChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.20230—
+1K223150APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd.20230—
+1K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+1K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+1K153034aap LOQTEQ VA Radius Set 2.5Aap Implantate AG20160—
+1K152145OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20151—
+1K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A20148—
+1K120015Osteomed Wrist Plating SystemOsteomed LP20122—
+1K093761Optilock VL (Variable Angle Locking) Distal Radius Plating SystemBiomet Trauma (Aka Ebi, Lp)20103—
+2K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+2K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+2K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+2K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+2K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+2K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+2K161041OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20160—
+2K150675Dorsal Spanning PlateSkeletal Dynamics, LLC20151—
+2K110271Maestro Wrist Plating SystemBiomet Manufacturing Corp20110—
+3K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+3K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+3K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+3K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+3K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+3K212601DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company20220—
+3K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—