510(k) Report

Devices descending from K081684

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+1K111448Icon (TM) Modular Pedicle Screw SystemOrthofix, Inc.20120—
+1K102204Choice Spine Starfire Pedicle Screw SystemChoicespine, LP201088—
+1K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088—
+1K100044Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone2010117—
+1K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc.20091301
+1K082797Blackstone Pedicle Screw SystemBlackstone Medical, Inc.2008209—
+2K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+2K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+2K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+2K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+2K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+2K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+2K150283Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20154—
+2K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+2K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine201482—
+2K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+2K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+2K122901Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix2012116—
+2K111183Ascent Posterior Occipital Thoracic (Poct) System (Titanium & Cobalt Chrome Rods)Orthofix, Inc.201122—
+2K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+3K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+3K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+3K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+3K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+3K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+3K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+3K222789VADER® Pedicle System, G21 CementIcotec AG202352
+3K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+3K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+3K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+3K200303Reform Pedicle Screw SystemPrecision Spine202010—
+3K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+3K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+3K182721Choice Spine Navigation SystemChoicespine, LP20192—
+3K181495Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20183—
+3K172115Navigated Instrument SystemOrthofix, Inc.20184—
+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
+3K170942The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP20170—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K161842Overwatch Spine SystemAmendia, Inc.201661
+3K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+3K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP201673—
+3K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+3K150380ProMIS Fixation SystemPremia Spine, Ltd.20154—
+3K131833Centurion Poct SystemOrthofix, Inc.20142—
+3K132603Apex Spine SystemSpinecraft, LLC201325—
+3K130176Firebird Spinal Fixation SystemOrthofix20135—
+3K123939S4 Spinal SystemAesculap Implant Systems, Inc.20133—
+3K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+3K120564Calypso SystemHogan Lovells US LLP201216—
+3K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+4K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+4K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+4K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+4K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K240963Spinal SystemTeslake, Inc.20240—
+4K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+4K232628VADER® Pedicle SystemIcotec AG20241—
+4K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+4K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+4K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+4K231844ProMIS™ Fixation SystemPremia Spine, Ltd.20231—
+4K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+4K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+4K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+4K193219G Surgical Marksman SystemG Surgical, LLC20191—
+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—
+4K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+4K182598VersaLink™ Fixation SystemPremia Spine, Ltd.20180—
+4K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+4K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+4K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+4K180433Ennovate®Aesculap Implant Systems, LLC201811
+4K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+4K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+4K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+4K172194Connector SystemOrthofix, Inc.2017162
+4K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+4K170061ProMIS™ Fixation SystemPremia Spine, Ltd.20170—
+4K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+4K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+4K150417Astra Spine SystemSpinecraft, LLC201521—
+4K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+4K132303Implanet Spine SystemImplanet, S.A.201315—