510(k) Report

Devices descending from K011583

30 later devices reach Spiked Washer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+1K092381Ibalance Akrfx Medial Opening Wedge Tibial System, Ifx Medial Peek Implant and Anchor…Ibalance Medical, Inc.20090—
+1K033303Wafer SystemSpine Wave, Inc.200423—
+2K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+2K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+2K053336Staxx FX SystemSpine Wave, Inc.200612—
+2K052670Staxx XD SystemSpine Wave, Inc.20068—
+3K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+3K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+3K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+3K140563Lateral VBR SystemNu Vasive, Incorporated20140—
+3K102315Staxx XDL SystemSpine Wave, Inc.20113—
+3K111469Staxxsd SystemSpine Wave, Inc.20110—
+3K090315Staxx XD SystemSpine Wave, Inc.20096—
+3K080108Cortoss Bone Augmentation MaterialOrthovita, Inc.200904
+3K080860Creaspine Supstance Small Vertebral Body Replacement SystemCreaspine20080—
+3K063606Modification to Staxx FX SystemSpine Wave, Inc.200711—
+4K132817Kiva VCF Treatment SystemBenvenue Medical, Inc.20149—
+4K133207Staxx (R) SystemSpine Wave, Inc.20131—
+4K101288Staxx XD SystemSpine Wave, Inc.201051
+5K191709V-STRUT Vertebral ImplantHyprevention Sas20202—
+5K181262SpineJack Expansion KitVexim SA20184—
+5K142996StaXx (R) XD SystemSpine Wave, Inc.20150—
+5K141141Kiva VCF Treatment SystemBenvenue Medical, Inc.20140—
+6K240084V-STRUT® Vertebral ImplantHyprevention20240—
+6K221697Injection Pin (Kip (02031-02061) (03031-03061))Slk Ortho, LLC20230—
+6K202393SpineJack Expansion KitStryker Corporation20203—
+7K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+8K223294SpineJack® Expansion KitStryker Instruments20221—
+9K250637VCFix Spinal SystemAmber Implants20250—