510(k) Report

Devices descending from K981251

124 later devices reach Kyphon Inflatable Bone Tamp through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH20230—
+6K221697Injection Pin (Kip (02031-02061) (03031-03061))Slk Ortho, LLC20230—
+6K202393SpineJack Expansion KitStryker Corporation20203—
+6K201115Next Generation Balloon Dilation SystemAcclarent, Inc.20200—
+6K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.20171—
+6K121943Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201217—
+6K120735Pathassit Light SeekerEntellus Medical, Inc.20121—
+7K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+7K160770Vent-Os Sinus Dilation familySinusys Corporation20160—
+7K133563Pathassist Light SeekerEntellus Medical, Inc.20130—
+7K132440Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201314—
+8K223294SpineJack® Expansion KitStryker Instruments20221—
+8K142252XprESS Multi-Sinus Dilation ToolEntellus Medical, Inc.201413—
+9K250637VCFix Spinal SystemAmber Implants20250—
+9K152434XprESS Multi-Sinus Dilation SystemEntellus Medical, Inc.201511—
+10K230258BB 8 Sinus Dilation KitExcelent, Inc.20230—
+10K163509XprESS ENT Dilation SystemEntellus Medical, Inc.20179—
+11K220027Audion ET dilation systemEntellus Medical, Inc.20220—
+11K210841NuVent Eustachian Tube Dilation BalloonMedtronic Xomed, Inc.20210—
+11K201398SINUSPRIME Dilation SystemStryker Ent20200—
+11K171761ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20185—
+12K230742ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc.20231—
+12K223542TubaVent Balloon Dilatation SystemSpiggle & Theis Medizintechnik GmbH20230—
+13K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20260—