510(k) Report

Devices descending from K853033

696 later devices reach Hartshill Rect & Wires, Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+8K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+8K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+8K171582NEO Pedicle Screw System™Neo Medical SA20170—
+8K171321K2M Navigation InstrumentsK2m201711
+8K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+8K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+8K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+8K170061ProMIS™ Fixation SystemPremia Spine, Ltd.20170—
+8K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+8K161028K2M Growing Spine SystemK2m, Inc.20163—
+8K161369EVEREST Spinal SystemK2m, Incorporated20169—
+8K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+8K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+8K151216Everest Spinal SystemK2m, Inc.201511—
+8K151755OASYS (r) SystemStryker Corporation201533—
+8K150417Astra Spine SystemSpinecraft, LLC201521—
+8K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+8K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+8K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+8K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+8K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+8K133402K2M Modular HooksK2m, Inc.20140—
+8K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+8K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+8K131343Reform Pedicle Screw SystemSpinal USA201331—
+8K130279Reform Pedicle Screw SystemSpinal USA201331—
+8K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+8K123373Nautilus Spinal SystemLife Spine201317—
+8K111953Nautilus Spinal SystemLife Spine20123—
+8K090320Conquest Spinal SystemLife Spine20092—
+9K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+9K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+9K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+9K262094E3D™-C Interbody SystemEvolution Spine20260—
+9K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.20260—
+9K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+9K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+9K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+9K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+9K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+9K260038E3D™-C Interbody SystemEvolution Spine20261—
+9K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+9K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+9K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+9K252322SIros-X SystemGenesys Spine20250—
+9K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+9K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+9K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+9K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+9K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+9K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+9K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+9K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+9K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+9K231479TriALTIS Spine SystemMedos International SARL20238—
+9K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+9K223806VERTICALE® Triangular Fixation SystemSilony Medical GmbH20230—
+9K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+9K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+9K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+9K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+9K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+9K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+9K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+9K222789VADER® Pedicle System, G21 CementIcotec AG202352
+9K223273ASTRA Spine SystemSpinecraft, LLC20228—
+9K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+9K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+9K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+9K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+9K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+9K221244CD Horizon™ Spinal SystemMedtronic202220—
+9K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+9K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+9K211323ASTRA Spine SystemSpinecraft, LLC202112—
+9K203205Navigated Spine InstrumentsStryker Spine20218—
+9K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+9K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+9K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+9K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+9K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+9K192680Percusys® Plus Pedicle Screw SystemJoimax GmbH20190—
+9K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+9K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+9K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+9K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+9K181188EVEREST Spinal SystemK2m, Inc.20186—
+9K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+9K172115Navigated Instrument SystemOrthofix, Inc.20184—
+9K162921Navigated Instrument SystemOrthofix, Inc.20175—
+9K162786PASS LP Spinal SystemMedicrea International SA20176—
+9K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+9K153439PathLoc-C Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20160—
+9K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+9K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+9K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+9K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+10K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—