510(k) Report

Devices descending from K973812

30 later devices reach Arthrex Puddu Osteotomy System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151456Small Bone Nail ImplantVilex IN Tennessee, Inc.20150—
+1K100604Otis -C PlusSciences ET Bio Materiaux (Sbm)20102—
+1K080992Aesculap Implant Systems High Tibial Osteotomy Plating SystemAesculap Implant Systems, Inc.20081—
+1K033303Wafer SystemSpine Wave, Inc.200423—
+2K140226Otis-C-Plus, Neotis Plate, Screw 06.5Science For Biomaterials20140—
+2K120818Otis-C PlusScience For Biomaterials20121—
+2K102505Hto Plating SystemAesculap Implant Systems, LLC20100—
+2K092381Ibalance Akrfx Medial Opening Wedge Tibial System, Ifx Medial Peek Implant and Anchor…Ibalance Medical, Inc.20090—
+2K053336Staxx FX SystemSpine Wave, Inc.200612—
+2K052670Staxx XD SystemSpine Wave, Inc.20068—
+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—