510(k) Report

Devices descending from K082797

209 later devices reach Blackstone Pedicle Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+4K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+4K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+4K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+4K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+4K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+4K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+4K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+4K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+4K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+4K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+4K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+4K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+4K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+4K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+4K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+4K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+4K172194Connector SystemOrthofix, Inc.2017162
+4K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K170964Zenius Spinal SystemMedyssey USA, Inc.20170—
+4K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+4K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K162786PASS LP Spinal SystemMedicrea International SA20176—
+4K162764Jazz Frame SystemImplanet, S.A.20176—
+4K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+4K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+4K153404Zavation Spinal SystemZavation, LLC20161—
+4K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+4K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+4K141850Flospine Pedicle Screw SystemFlospine20140—
+5K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+5K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+5K252437JAZZ Spinal SystemImplanet20250—
+5K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+5K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+5K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+5K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+5K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+5K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+5K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+5K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+5K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+5K231658VEOS Spinal Fixation SystemSpineway20230—
+5K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+5K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+5K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+5K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+5K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+5K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+5K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+5K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+5K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+5K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+5K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+5K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+5K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+5K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+5K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+5K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+5K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+5K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+5K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+5K191217Jazz PFImplanet, S.A.20190—
+5K190751Connector SystemOrthofix, Inc.20193—
+5K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+5K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+5K182240PASS LP Spinal SystemMedicrea International SA20182—
+5K171881JAZZ Passer BandImplanet, S.A.20170—
+5K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+5K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+6K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+6K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+6K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+6K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+6K252322SIros-X SystemGenesys Spine20250—
+6K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+6K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+6K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+6K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+6K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+6K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+6K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+6K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K220025ARx® Spinal SystemLife Spine, Inc.20220—
+6K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+6K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+6K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+6K203506PERLA® TL posterior osteosynthesis systemSpineart202132