510(k) Report

Devices descending from K040612

13 later devices reach Sky Bone Expander System (Sky System) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K053336Staxx FX SystemSpine Wave, Inc.200612—
+2K080108Cortoss Bone Augmentation MaterialOrthovita, Inc.200904
+2K063606Modification to Staxx FX SystemSpine Wave, Inc.200711—
+3K132817Kiva VCF Treatment SystemBenvenue Medical, Inc.20149—
+4K191709V-STRUT Vertebral ImplantHyprevention Sas20202—
+4K181262SpineJack Expansion KitVexim SA20184—
+4K141141Kiva VCF Treatment SystemBenvenue Medical, Inc.20140—
+5K240084V-STRUT® Vertebral ImplantHyprevention20240—
+5K221697Injection Pin (Kip (02031-02061) (03031-03061))Slk Ortho, LLC20230—
+5K202393SpineJack Expansion KitStryker Corporation20203—
+6K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+7K223294SpineJack® Expansion KitStryker Instruments20221—
+8K250637VCFix Spinal SystemAmber Implants20250—