510(k) Report

Devices descending from K153575

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252901Tyber Medical Trauma ScrewTyber Medical, LLC20250—
+1K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+1K203595DynaFuse Fixation SystemMedShape, Inc.20225—
+1K161597Tyber Medical BioTy® Nanotopography Trauma ScrewTyber Medical, LLC20161—
+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—
+2K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+2K233567OsteoCoil™ Nitinol Compression System (Multiple Component PNs)Flower Orthopedics Corporation Dba Conventus Flower Ortho20241—
+2K170571Tyber Medical BioTy (TM) Nanotopography Trauma Screw, TyFix ScrewTyber Medical, LLC20170—
+3K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower Orthoped20260—
+3K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—