510(k) Report

Devices descending from K001945

112 later devices reach Synthes (Usa) Medial Distal Tibia Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+6K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+6K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+7K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+7K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+7K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+7K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+7K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+8K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+8K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+8K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+8K233919VariAx 2 Distal Radius SystemStryker GmbH20242—