510(k) Report

Devices descending from K003227

526 later devices reach Bio-Absorbable Corkscrew Model AR-1920B through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20250—
+8K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+8K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+8K241912BiochargeNanofiber Solutions, LLC20240—
+8K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+8K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+8K231641Rotium Bioresorbable WickNanofiber Solutions, LLC20231—
+8K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20237—
+8K222564Treace Medical Concepts (TMC) Hammertoe Fixation SystemTreace Medical Concepts, Inc.20220—
+8K213109Auxilock Draw Tight Suture-Based AnchorAuxein Medical Private Limited20220—
+8K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+8K201414Rotium Bioresorbable WickNanofiber Solutions, LLC20202—
+8K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+8K190658MIS Bunion Plating SystemCrossroads Extremity Systems, LLC20192—
+9K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+9K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+9K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+9K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+9K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+9K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+9K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+10K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+10K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+10K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+10K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+10K233919VariAx 2 Distal Radius SystemStryker GmbH20242—