510(k) Report

Devices descending from K984377

672 later devices reach Synthes Spine Cervifix System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+7K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+7K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+7K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+7K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+7K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+7K131343Reform Pedicle Screw SystemSpinal USA201331—
+7K130279Reform Pedicle Screw SystemSpinal USA201331—
+7K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+7K123373Nautilus Spinal SystemLife Spine201317—
+7K111953Nautilus Spinal SystemLife Spine20123—
+7K090320Conquest Spinal SystemLife Spine20092—
+8K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+8K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+8K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.20260—
+8K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+8K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+8K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+8K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+8K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+8K260038E3D™-C Interbody SystemEvolution Spine20261—
+8K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+8K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+8K252322SIros-X SystemGenesys Spine20250—
+8K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+8K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+8K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+8K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+8K233366SYMPHONY OCT SystemMedos International SARL20230—
+8K231479TriALTIS Spine SystemMedos International SARL20238—
+8K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+8K223806VERTICALE® Triangular Fixation SystemSilony Medical GmbH20230—
+8K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+8K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+8K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+8K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+8K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+8K222789VADER® Pedicle System, G21 CementIcotec AG202352
+8K223273ASTRA Spine SystemSpinecraft, LLC20228—
+8K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+8K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+8K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+8K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+8K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+8K221244CD Horizon™ Spinal SystemMedtronic202220—
+8K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+8K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+8K211323ASTRA Spine SystemSpinecraft, LLC202112—
+8K203205Navigated Spine InstrumentsStryker Spine20218—
+8K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+8K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+8K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+8K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+8K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+8K192680Percusys® Plus Pedicle Screw SystemJoimax GmbH20190—
+8K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+8K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+8K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+8K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+8K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+8K172115Navigated Instrument SystemOrthofix, Inc.20184—
+8K162921Navigated Instrument SystemOrthofix, Inc.20175—
+8K162786PASS LP Spinal SystemMedicrea International SA20176—
+8K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+8K153439PathLoc-C Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20160—
+8K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+8K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+8K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+9K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+9K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+9K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+9K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+9K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K243249TriALTIS™ Spine SystemMedos International SARL20250—
+9K243693NEO Pedicle Screw System™Neo Medical SA20240—
+9K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+9K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+9K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q…Stryker Leibinger GmbH & Co KG20247—
+9K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+9K232628VADER® Pedicle SystemIcotec AG20241—
+9K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+9K233684TriALTIS™ Spine SystemMedos International SARL20234—
+9K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+9K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—