510(k) Report

Devices descending from K000682

340 later devices reach Synthes Large Fragment Dynamic Compression Locking (DCL) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+5K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+5K211051DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)DePuy Synthes20211—
+5K193452MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC20203—
+5K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+5K191009Arsenal Plating SystemTrilliant Surgical20192—
+5K181091AxSOS 3 TiStryker GmbH201811—
+5K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+5K173135VariAx 2 SystemStryker GmbH201713—
+5K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+6K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+6K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+6K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+6K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+6K254054VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating SystemSynthes GmbH20260—
+6K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.20240—
+6K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+6K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+6K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+6K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+6K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+6K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+6K201149CoLink Plating SystemIn2bones USA, LLC20200—
+6K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+6K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+6K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+6K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+6K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+6K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+6K180500VariAx 2 SystemStryker GmbH201812—
+7K253178TRILEAP Plating SystemCrossroads Extremity Systems20260—
+7K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+7K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+7K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+7K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+7K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+8K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+8K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+8K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+9K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—