510(k) Report

Devices descending from K951657

438 later devices reach VSP (Variable Screw Placement) Spinal Fixation System, Pedicle Screw (S)… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K201006K2M Navigation InstrumentsK2m, Inc.20200—
+7K200070ARx Spinal SystemLife Spine, Inc.20209—
+7K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+7K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+7K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+7K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+7K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+7K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+7K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+7K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+7K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+7K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+7K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+7K172194Connector SystemOrthofix, Inc.2017162
+7K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+7K152174Sniper Spine SystemSpine Wave, Inc.20158—
+7K151216Everest Spinal SystemK2m, Inc.201511—
+7K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+7K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+7K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+7K123373Nautilus Spinal SystemLife Spine201317—
+7K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+7K111953Nautilus Spinal SystemLife Spine20123—
+7K120292Caplox II Pedicle Screw SystemCaptiva Spine, Inc.2012151
+7K090320Conquest Spinal SystemLife Spine20092—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+8K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+8K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+8K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+8K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+8K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+8K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+8K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+8K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+8K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+8K232432E3D™-A Interbody SystemEvolution Spine20248—
+8K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+8K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+8K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+8K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+8K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+8K231658VEOS Spinal Fixation SystemSpineway20230—
+8K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+8K230762EDEN Spinal Fixation MIS SystemJmt Co., Ltd.20230—
+8K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+8K222789VADER® Pedicle System, G21 CementIcotec AG202352
+8K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+8K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+8K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+8K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+8K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+8K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+8K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+8K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+8K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+8K210549ARx Spinal SystemLife Spine, Inc.20211—
+8K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+8K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+8K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+8K190751Connector SystemOrthofix, Inc.20193—
+8K160003Sniper (R) Spine SystemSpine Wave, Inc.20167—
+8K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+8K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+8K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+8K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+8K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+8K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+9K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+9K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+9K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+9K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+9K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+9K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+9K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+9K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+9K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+9K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+9K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+9K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+9K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+9K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+9K241846E3D™-C Interbody SystemEvolution Spine20246—
+9K233256Robotic Integration InstrumentsDePuy Synthes20240—
+9K240368E3D™-A Interbody SystemEvolution Spine20247—
+9K240392JAZZ Spinal SystemImplanet20241—
+9K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+9K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+9K232628VADER® Pedicle SystemIcotec AG20241—
+9K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+9K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+9K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+9K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371