510(k) Report

Devices descending from K010246

78 later devices reach Kyphx Inflatable Bone Tamp, Size 20/3,Model K01A, Kyphx Inflatable Bone Tamp… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133669Medinaut Kyphoplasty SystemImedicom20147—
+1K132817Kiva VCF Treatment SystemBenvenue Medical, Inc.20149—
+1K122503Parallax Balloon Inflatable Bone Tamp-10 MM Balloon Parallax Balloon Inflatable Bone…Neuro Therm, Inc.20130—
+1K122533Osseoflex SB Inflatable Bone TampOsseon Therapeutics, Inc.20128—
+1K041454Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13AKyphon, Inc.2004735
+1K040939Sky Bone Expander System (Sky System)Disc-O-Tech Medical Technologies, Ltd.20040—
+1K034037Sky Bone Expander SystemDisc-O-Tech Medical Technologies, Ltd.200415—
+1K032358B-Twin Bone Expander System (B-Twin BE System)Disc-O-Tech Medical Technologies, Ltd.200316—
+2K202027Balex bone Expander SystemTaeyeon Medical Co., Ltd.20211—
+2K191709V-STRUT Vertebral ImplantHyprevention Sas20202—
+2K192335TRACKER Kyphoplasty SystemGS Medical Co., Ltd.20191—
+2K181262SpineJack Expansion KitVexim SA20184—
+2K153296MEDINAUT Kyphoplasty SystemImedicom Co., Ltd.20164—
+2K151532KYPHON ELEMENT Inflatable Bone TampMedtronic, Inc.20150—
+2K141930Osseoflex SB, 10G/4ML, Osseoflex SB, 10G/2MLOsseon, LLC20146—
+2K141141Kiva VCF Treatment SystemBenvenue Medical, Inc.20140—
+2K140937Osseoflex SBOsseon, LLC20147—
+2K132620Inter V Kyphoplasty Catheter (Balloon Length: 0 MM), Interv Kyphoplasty Catheter…Pan Medical, Ltd.20145—
+2K130146Synthes Synflate Vertevral Balloon SystemSynthes (Usa), LLC20130—
+2K123942Stryker Ivas Balloon CatheterStryker Corporation201351
+2K113154Ivas Balloon CatheterStryker Corporation20123—
+2K113477Ivas 20MM (10 Gauge) Balloon CatheterStryker Instruments, Instruments Div.20127—
+2K110604VBB SystemSynthes201111
+2K093477Shield Kyphoplasty SystemSoteira, Inc.20110—
+2K111593Guardian Inflatable Bone Expander SystemBm Korea Co., Ltd.20112—
+2K110998Affirm (TM) VCF SystemAlgea Therapies20116—
+2K103807Ivas 2-10MM (10 Guage) Ballon CatheterStryker Corporation20119—
+2K103064Avamax Vertebral BalloonCare Fusion201122—
+2K101864Kyphon Xpander II Inflatable Bone TampMedtronic20105—
+2K093419Ivas 2-10MM (10 Gauge) Balloon Catheter, Ivas 2-15 MM (10 Gauge)0705-115-500, Ivas…Stryker Instruments, Instruments Div.201013—
+2K093463Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020Care Fusion201023—
+2K090211Inflatable Bone TampCardinal Health, Inc.200924—
+2K072198X-Void, SpiderSintea Biotech, Inc.20081—
+2K080158LB Medical Inflatable Tissue Elevator/Expander SystemLb Medical LLC20080—
+2K053336Staxx FX SystemSpine Wave, Inc.200612—
+2K040612Sky Bone Expander System (Sky System)Disc-O-Tech Medical Technologies, Ltd.200413—
+3K232842Balloon Inflation SystemNingbo Hicren Biotechnology Co., Ltd.20240—
+3K240084V-STRUT® Vertebral ImplantHyprevention20240—
+3K221142Kyphoplasty Balloon SystemOK Medinet Korea Co., Ltd.20230—
+3K221697Injection Pin (Kip (02031-02061) (03031-03061))Slk Ortho, LLC20230—
+3K211797TRACKER Plus Kyphoplasty SystemGS Medical Co., Ltd.20210—
+3K202393SpineJack Expansion KitStryker Corporation20203—
+3K200763Osteo-site Vertebral BalloonIzi Medical20200—
+3K191596Arcadia Balloon CatheterMerit Medical Systems, Inc.20190—
+3K181752Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon…Stryker Corporation20180—
+3K172871SpineKure Kyphoplasty SystemHanchang Co., Ltd.20180—
+3K172116Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon…Stryker Corporation20181—
+3K16245313G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)Pan Medical, Ltd.20161—
+3K152557Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon CathetersG21, S.R.L.20162—
+3K150607Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2mlOsseon, LLC20154—
+3K150322InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter…Pan Medical, Ltd.20154—
+3K143006GUARDIAN-SG Inflatable Bone Expander SystemBm Korea Co., Ltd.20151—
+3K141419ZvplastyZavation, LLC2014036
+3K131820Avamax Vertebral Balloon System, 8G, Avamax Vertebral Balloon System, 10G, Avamax…Care Fusion20138—
+3K131824Avaflex Vertebral Balloon SystemCare Fusion20133—
+3K130430Ivas 10MM and 15MM Balloon CatheterStryker Corporation201351
+3K130402Spider System Kolibri Cement NeedleSintea Plustek, LLC20130—
+3K123771Kyphon Express II Inflatable Bone TampsMedtronic20123—
+3K080108Cortoss Bone Augmentation MaterialOrthovita, Inc.200904
+3K063606Modification to Staxx FX SystemSpine Wave, Inc.200711—
+4K231340Renova Spine Balloon CatheterBiopsybell S.R.L.20230—
+4K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+4K192449Joline Kyphoplasty System AllevoJoline GmbH & Co. KG20203—
+4K172214Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon CathetersG-21 S.R.L.20171—
+4K162283DCM Kyphoplasty SystemDragon Crown Medical Co., Ltd.20170—
+4K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+4K151125AVAflex Vertebral Balloon SystemCare Fusion20151—
+4K150523AVAmax Vertebral BalloonCare Fusion20151—
+5K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+5K223709Kyphoplasty Balloon CatheterJiangsu Changmei Medtech Co., Ltd.20232—
+5K223294SpineJack® Expansion KitStryker Instruments20221—
+5K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+5K162062AVAmax Vertebral Balloon, AVAflex Vertebral BalloonStryker Corporation20160—
+6K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.20260—
+6K252458Kyphoplasty Balloon Dilatation CathetersShanghai Lange Medtech Co., Ltd.20250—
+6K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+6K250637VCFix Spinal SystemAmber Implants20250—
+6K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—