510(k) Report

Devices descending from K013885

300 later devices reach Blackstone Spinal Fixation System Posterior Hooks through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+5K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+5K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+5K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+5K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+5K222789VADER® Pedicle System, G21 CementIcotec AG202352
+5K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+5K222628Life Spine ALIF Buttress Plate SystemLife Spine, Inc.20220—
+5K220025ARx® Spinal SystemLife Spine, Inc.20220—
+5K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+5K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+5K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+5K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+5K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+5K200956NuVasive Thoracolumbar PlatesNu Vasive, Incorporated20200—
+5K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+5K193219G Surgical Marksman SystemG Surgical, LLC20191—
+5K182721Choice Spine Navigation SystemChoicespine, LP20192—
+5K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+5K181495Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20183—
+5K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+5K172115Navigated Instrument SystemOrthofix, Inc.20184—
+5K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+5K170942The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP20170—
+5K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+5K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+5K161842Overwatch Spine SystemAmendia, Inc.201661
+5K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP201673—
+5K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+5K150380ProMIS Fixation SystemPremia Spine, Ltd.20154—
+5K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+5K150417Astra Spine SystemSpinecraft, LLC201521—
+5K131833Centurion Poct SystemOrthofix, Inc.20142—
+5K123939S4 Spinal SystemAesculap Implant Systems, Inc.20133—
+5K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+5K120564Calypso SystemHogan Lovells US LLP201216—
+5K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+6K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+6K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+6K252322SIros-X SystemGenesys Spine20250—
+6K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+6K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+6K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+6K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+6K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K232628VADER® Pedicle SystemIcotec AG20241—
+6K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+6K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+6K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+6K233366SYMPHONY OCT SystemMedos International SARL20230—
+6K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+6K231844ProMIS™ Fixation SystemPremia Spine, Ltd.20231—
+6K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+6K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+6K211323ASTRA Spine SystemSpinecraft, LLC202112—
+6K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+6K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+6K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+6K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+6K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+6K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+6K182598VersaLink™ Fixation SystemPremia Spine, Ltd.20180—
+6K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+6K180433Ennovate®Aesculap Implant Systems, LLC201811
+6K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+6K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+6K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K170061ProMIS™ Fixation SystemPremia Spine, Ltd.20170—
+6K162786PASS LP Spinal SystemMedicrea International SA20176—
+6K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+6K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+6K132303Implanet Spine SystemImplanet, S.A.201315—
+6K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+6K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+6K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+6K120838Synthes Matrix SystemSynthes Spine201216—
+7K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+7K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K240392JAZZ Spinal SystemImplanet20241—
+7K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+7K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+7K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+7K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+7K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+7K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—