510(k) Report

Devices descending from K112111

49 later devices reach Acu-Sinch Repair System and Acumed Suture Anchor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212990Acumed Ankle Syndesmosis Repair SystemAcumed, LLC20220—
+1K210750Acumed Clavicle Hook Plating SystemAcumed, LLC20210—
+1K192984APTUS Clavicle SystemMedartis AG20206—
+1K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+1K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics201240—
+2K260761APTUS Clavicle System 2.8Medartis AG20260—
+2K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+2K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+2K191972ARIX Wrist SystemJeil Medical Corporation20190—
+2K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+2K132502Variax 2 SystemStryker Trauma AG201321—
+2K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+3K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+3K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+3K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+3K173556Injection ScrewBiedermann Medtech, Inc.20180—
+3K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+3K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+3K140769Variax 2 SystemStryker Trauma AG201419—
+4K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+4K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+4K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+4K173135VariAx 2 SystemStryker GmbH201713—
+4K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+5K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+5K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+5K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+5K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+5K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+5K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+5K180500VariAx 2 SystemStryker GmbH201812—
+6K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+6K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+6K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+6K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+6K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+6K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+6K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+6K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+7K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+7K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+7K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+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—
+8K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+8K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+8K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+8K233919VariAx 2 Distal Radius SystemStryker GmbH20242—