510(k) Report

Devices descending from K031090

891 later devices reach Modification to Xia Stainless Steel System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+6K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+6K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+6K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+6K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+6K143350Nile Alternative FixationK2m, Inc.201510—
+6K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+6K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+6K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+6K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+6K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+6K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+6K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+6K133402K2M Modular HooksK2m, Inc.20140—
+6K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+6K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+6K133103Aversion Pedicle Screw SystemK7, LLC20140—
+6K133369Tiger Spine SystemCorelink, LLC201429—
+6K131250Tiger Spine SystemCorelink, LLC201340—
+6K131784Range Spinal SystemK2m, Inc.201334—
+6K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+6K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+6K131343Reform Pedicle Screw SystemSpinal USA201331—
+6K130279Reform Pedicle Screw SystemSpinal USA201331—
+6K131030Range Spinal SystemK2m, Inc.201334—
+6K130330Range Spinal SystemK2m, Inc.201336—
+6K123939S4 Spinal SystemAesculap Implant Systems, Inc.20133—
+6K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+6K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+6K122145Lanx Spinal Fixation SystemLanx, Inc.201271
+6K120564Calypso SystemHogan Lovells US LLP201216—
+6K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+6K121020Viper SystemDepuy Spine, Inc.201294—
+6K113044Synthes MirsSynthes Spine2011933
+6K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+6K111957Polaris Spinal SystemBiomet Spine (Ebi, LLC)201176—
+6K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+6K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+6K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+6K100845Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500 SeriesZimmer Spine, Inc.201045
+7K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+7K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+7K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+7K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+7K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+7K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+7K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+7K260038E3D™-C Interbody SystemEvolution Spine20261—
+7K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+7K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+7K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+7K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K250637VCFix Spinal SystemAmber Implants20250—
+7K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+7K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+7K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+7K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+7K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+7K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+7K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+7K232432E3D™-A Interbody SystemEvolution Spine20248—
+7K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+7K231479TriALTIS Spine SystemMedos International SARL20238—
+7K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+7K230762EDEN Spinal Fixation MIS SystemJmt Co., Ltd.20230—
+7K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+7K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+7K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+7K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+7K222789VADER® Pedicle System, G21 CementIcotec AG202352
+7K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+7K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+7K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+7K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+7K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+7K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+7K203023Pisces Spinal SystemOrtho Development Corporation20210—
+7K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+7K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+7K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+7K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+7K202305Zavation IBF SystemZavation Medical Products, LLC20209—