510(k) Report

Devices descending from K012870

908 later devices reach Xia Stainless Steel System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+8K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+8K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+8K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+8K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+8K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+8K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+8K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+8K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+8K221244CD Horizon™ Spinal SystemMedtronic202220—
+8K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+8K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+8K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+8K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+8K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+8K203452Nano FortiFix® SystemNanovis, LLC20200—
+8K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+8K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+8K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+8K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+8K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+8K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+8K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+8K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+8K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+8K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+8K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+8K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+8K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+8K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+8K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+8K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+8K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+8K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH20186—
+8K172417SILC® Fixation SystemGlobus Medical, Inc.20171—
+8K172194Connector SystemOrthofix, Inc.2017162
+8K162921Navigated Instrument SystemOrthofix, Inc.20175—
+8K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+8K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+8K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+8K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+8K153404Zavation Spinal SystemZavation, LLC20161—
+8K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+8K141850Flospine Pedicle Screw SystemFlospine20140—
+9K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.20260—
+9K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+9K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+9K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+9K250769Dakota LP SystemPrecision Spine, Inc.20250—
+9K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+9K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+9K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+9K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+9K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+9K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+9K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+9K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+9K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+9K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+9K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+9K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+9K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+9K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+9K231658VEOS Spinal Fixation SystemSpineway20230—
+9K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+9K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+9K223806VERTICALE® Triangular Fixation SystemSilony Medical GmbH20230—
+9K230329F3D Interbody SystemCorelink, LLC20230—
+9K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+9K223494CD Horizon Spinal SystemMedtronic202317—
+9K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+9K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+9K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+9K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+9K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+9K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+9K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+9K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+9K191217Jazz PFImplanet, S.A.20190—
+9K190751Connector SystemOrthofix, Inc.20193—
+9K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+9K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+9K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+9K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+9K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+9K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+9K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+10K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+10K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+10K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+10K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+10K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+10K253331PressON Spinal Fixation SystemNexus Spine20250—
+10K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+10K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+10K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+10K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+10K243693NEO Pedicle Screw System™Neo Medical SA20240—
+10K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—