510(k) Report

Devices descending from K082797

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+1K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+1K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+1K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+1K122901Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix2012116—
+1K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088—
+1K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+1K100044Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone2010117—
+1K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc.20091301
+2K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+2K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+2K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+2K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+2K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+2K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+2K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+2K222789VADER® Pedicle System, G21 CementIcotec AG202352
+2K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+2K200303Reform Pedicle Screw SystemPrecision Spine202010—
+2K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+2K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+2K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+2K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+2K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+2K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+2K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+2K132603Apex Spine SystemSpinecraft, LLC201325—
+2K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+2K130176Firebird Spinal Fixation SystemOrthofix20135—
+2K123939S4 Spinal SystemAesculap Implant Systems, Inc.20133—
+2K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+2K120564Calypso SystemHogan Lovells US LLP201216—
+2K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+2K111183Ascent Posterior Occipital Thoracic (Poct) System (Titanium & Cobalt Chrome Rods)Orthofix, Inc.201122—
+3K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+3K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+3K240963Spinal SystemTeslake, Inc.20240—
+3K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+3K232628VADER® Pedicle SystemIcotec AG20241—
+3K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+3K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+3K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+3K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+3K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+3K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+3K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+3K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+3K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+3K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+3K193219G Surgical Marksman SystemG Surgical, LLC20191—
+3K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+3K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+3K180433Ennovate®Aesculap Implant Systems, LLC201811
+3K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+3K172115Navigated Instrument SystemOrthofix, Inc.20184—
+3K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+3K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+3K170647Connector SystemOrthofix, Inc.201718—
+3K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+3K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+3K161842Overwatch Spine SystemAmendia, Inc.201661
+3K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+3K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+3K150417Astra Spine SystemSpinecraft, LLC201521—
+3K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+3K131833Centurion Poct SystemOrthofix, Inc.20142—
+3K132303Implanet Spine SystemImplanet, S.A.201315—
+3K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+3K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+3K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+3K120838Synthes Matrix SystemSynthes Spine201216—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+4K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+4K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+4K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+4K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+4K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+4K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K233256Robotic Integration InstrumentsDePuy Synthes20240—
+4K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+4K240392JAZZ Spinal SystemImplanet20241—
+4K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+4K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+4K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+4K223273ASTRA Spine SystemSpinecraft, LLC20228—
+4K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+4K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+4K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K211323ASTRA Spine SystemSpinecraft, LLC202112—
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—