510(k) Report

Devices descending from K070946

132 later devices reach Synthes LCP Diaphyseal-Metaphyseal (Dia-Meta) Volar Distal Radius Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K152306MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC20157—
+4K142306Flower Upper Extremity Plating SetFlower Orthopedics Corporation20140—
+4K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+4K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+4K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+4K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+4K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+5K262975Arthrex Beaming SystemArthrex, Inc.20260—
+5K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+5K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+5K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+5K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+5K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+5K210750Acumed Clavicle Hook Plating SystemAcumed, LLC20210—
+5K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+5K180500VariAx 2 SystemStryker GmbH201812—
+5K173710MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC201841
+5K160300MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC20166—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+6K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+6K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+6K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+6K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™…Crossroads Extremity Systems, LLC20232—
+6K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+6K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+6K193452MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC20203—
+6K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+7K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+7K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+7K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+8K253178TRILEAP Plating SystemCrossroads Extremity Systems20260—