510(k) Report

Devices descending from K950709

541 later devices reach Synergy TI Anterior Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+5K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+5K212692Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation202146—
+5K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+5K211606Mariner Deformity SystemSeaSpine Orthopedics Corporation2021471
+5K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+5K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+5K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+5K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+5K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+5K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+5K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+5K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+5K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+5K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation201949—
+5K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+5K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+5K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+5K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+5K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+5K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+5K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+5K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+5K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+5K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+5K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+5K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K161369EVEREST Spinal SystemK2m, Incorporated20169—
+5K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+5K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+5K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+5K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+5K150417Astra Spine SystemSpinecraft, LLC201521—
+5K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+5K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+5K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+5K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+5K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+5K133369Tiger Spine SystemCorelink, LLC201429—
+5K131250Tiger Spine SystemCorelink, LLC201340—
+5K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+5K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+5K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+5K123373Nautilus Spinal SystemLife Spine201317—
+5K111953Nautilus Spinal SystemLife Spine20123—
+5K120838Synthes Matrix SystemSynthes Spine201216—
+5K120696Tiger Spine SystemCorelink, LLC201241—
+5K110692Streamline TL Spinal SystemPioneer Surgical Technology, Inc.201189—
+5K102870Exactech Proliant Polyaxial Pedicle Screw SystemExactech, Inc.20119—
+5K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc.20091301
+5K090320Conquest Spinal SystemLife Spine20092—
+5K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+5K073245Extended Vertiflex Spinal Screw SystemVertiflex, Inc.200810—
+5K072685Ngarde SystemN Spine, Inc.200709
+5K043001MX Polyaxial Pedicle ScrewScient'X200437—
+5K042964MX Monoaxial Pedicle ScrewScient'X200438—
+5K042953Modification to Protex Stabilization SystemGlobus Medical, Inc.20040—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+6K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+6K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+6K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+6K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+6K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+6K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+6K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+6K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+6K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+6K233256Robotic Integration InstrumentsDePuy Synthes20240—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+6K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+6K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+6K231515MySpine Cervical GuidesMedacta International S.A.20230—
+6K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+6K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+6K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+6K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+6K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+6K223273ASTRA Spine SystemSpinecraft, LLC20228—
+6K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+6K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+6K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+6K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+6K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+6K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—