510(k) Report

Devices descending from K011206

35 later devices reach Parallax Bone and Vertebral Body Biopsy and Infusion Needles through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032943Stryker Vertebral Body and Bone Biopsy Kits, Stryker Capture Body and Bone Biospsy KitsStryker Corp.200329—
+1K022169Clearview Plus Bone and Vertebral Body Biopsy NeedlesParallax Medical, Inc.200234—
+2K170008Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle SetCook Incorporated20170—
+2K141673Ivas 8 Gauge Bone Biopsy KitStryker Corporation20140—
+2K113872The Oncontrol Bone Access and Bone Biopsy System by VidacareVidacare Corporation201222
+2K112468The Oncontrol Bone Access System by VidacareRegulatory Specialists, Inc.20113—
+2K070091Coaxial Bone and Vertebral Body Biopsy Needle Model# JBC1213, JBC1208Cardinal Health, Inc.20076—
+2K060148Ebi Vertebroplasty SystemsEbi, L.P.200618—
+2K052435Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc.20050—
+3K230015OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power…Laurane Medical Sas20230—
+3K213896BD Trek Powered Bone Biopsy SystemBard Peripheral Vascular20220—
+3K172558iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy KitStryker Corporation20171—
+3K171531Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow…Care Fusion201736
+3K070527Arcuate Vertebral Augmentation SystemMedtronic Sofamor Danek20071—
+3K063248Arcuate Vertebral Augmentation SystemMedtronic Sofamor Danek200717—
+4K242322Bone Marrow Biopsy NeedleZhejiang Curaway Medical Technology Co., Ltd.20250—
+4K192099MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone…Medax Srl Unipersonale20200—
+4K190177J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,Ranfac Corporation20190—
+4K180327Stryker iVAS 13g Bone Biopsy KitStryker Corporation20180—
+4K113452Acu-Cut Vertebral Augmentation SystemAscendx Spine, Inc.20120—
+4K072133Avaflex Vertebral Augmentation NeedleCardinal Health, Inc.20073—
+4K070293Benvenue VCF Osteo Coil SystemBenvenue Medical, Inc.200710—
+5K132817Kiva VCF Treatment SystemBenvenue Medical, Inc.20149—
+5K130402Spider System Kolibri Cement NeedleSintea Plustek, LLC20130—
+5K100479Parallax Contour Vertebral Augmentation DeviceArthrocare Corp.20101—
+6K191709V-STRUT Vertebral ImplantHyprevention Sas20202—
+6K181262SpineJack Expansion KitVexim SA20184—
+6K141141Kiva VCF Treatment SystemBenvenue Medical, Inc.20140—
+6K110183Arthrocare Parallax Contour Vertebral Augmentation DeviceArthrocare Corp.20110—
+7K240084V-STRUT® Vertebral ImplantHyprevention20240—
+7K221697Injection Pin (Kip (02031-02061) (03031-03061))Slk Ortho, LLC20230—
+7K202393SpineJack Expansion KitStryker Corporation20203—
+8K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+9K223294SpineJack® Expansion KitStryker Instruments20221—
+10K250637VCFix Spinal SystemAmber Implants20250—