510(k) Report

Devices descending from K133842

23 later devices reach Tyber Medical Trauma Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253042Tyber Medical Trauma ScrewTyber Medical, LLC20260—
+1K220723Hand Trauma Screw SystemSkeletal Dynamics, Inc.20221—
+1K203595DynaFuse Fixation SystemMedShape, Inc.20225—
+1K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+1K192974Tyber Medical Trauma ScrewTyber Medical, LLC20201—
+1K170571Tyber Medical BioTy (TM) Nanotopography Trauma Screw, TyFix ScrewTyber Medical, LLC20170—
+1K153575Tyber Medical Trauma ScrewTyber Medical, LLC201612—
+1K153180Tyber Medical MST Trauma ScrewTyber Medical, LLC20152—
+2K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+2K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+2K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+2K252901Tyber Medical Trauma ScrewTyber Medical, LLC20250—
+2K233567OsteoCoil™ Nitinol Compression System (Multiple Component PNs)Flower Orthopedics Corporation Dba Conventus Flower Ortho20241—
+2K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+2K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+2K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+2K230908Hand Trauma Threaded Nail SystemSkeletal Dynamics, Inc.20230—
+2K161597Tyber Medical BioTy® Nanotopography Trauma ScrewTyber Medical, LLC20161—
+3K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower Orthoped20260—
+3K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+3K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+3K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+4K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—