510(k) Report

Devices descending from K043565

834 later devices reach Modification to Dynesys Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K162764Jazz Frame SystemImplanet, S.A.20176—
+8K161369EVEREST Spinal SystemK2m, Incorporated20169—
+8K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+8K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161—
+8K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+8K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+8K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+8K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+8K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+8K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+8K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+8K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+8K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+8K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584—
+8K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+8K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+8K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+8K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+9K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+9K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+9K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+9K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+9K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+9K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+9K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+9K253249TriALTIS™ Spine SystemMedos International SARL20251—
+9K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+9K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+9K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+9K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+9K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+9K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+9K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+9K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+9K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+9K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+9K243249TriALTIS™ Spine SystemMedos International SARL20250—
+9K243693NEO Pedicle Screw System™Neo Medical SA20240—
+9K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+9K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+9K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+9K240160EGPS Navigated InstrumentsAstura Medical20240—
+9K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+9K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+9K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+9K241846E3D™-C Interbody SystemEvolution Spine20246—
+9K233256Robotic Integration InstrumentsDePuy Synthes20240—
+9K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K240368E3D™-A Interbody SystemEvolution Spine20247—
+9K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+9K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+9K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+9K233300POWEReam 1/4 DriveStryker Instruments20231—
+9K233684TriALTIS™ Spine SystemMedos International SARL20234—
+9K231515MySpine Cervical GuidesMedacta International S.A.20230—
+9K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+9K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+9K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+9K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+9K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+9K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+9K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+9K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+9K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+9K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+9K223558CUVIS-spineCurexo, Inc.20230—
+9K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+9K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+9K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+9K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+9K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+9K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+9K222789VADER® Pedicle System, G21 CementIcotec AG202352
+9K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+9K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+9K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+9K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+9K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+9K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+9K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+9K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+9K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+9K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+9K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+9K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+9K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+9K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+9K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+9K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+9K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+9K201569CUVIS-spineCurexo, Inc.20212—
+9K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+9K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+9K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+9K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—