510(k) Report

Devices descending from K020674

305 later devices reach Blackstone Spinal Fixation System 4.5MM Multi-Axial Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081684Blackstone Pedicle Screw SystemBlackstone Medical, Inc.20082773
+1K080407Blackstone SFS Parallel Rod ConnectorsBlackstone Medical, Inc.20082961
+1K042514Modification to Blackstone Modular Pedicle Screw SystemBlackstone Medical, Inc.200412
+1K030581Blackstone Spinal Fixation System Lateral Offset (System Modification)Blackstone Medical, Inc.2003298—
+1K030241Modification to Blackstone Spinal Fixation SystemBlackstone Medical, Inc.2003297—
+1K023498Modification to Blackstone Spinal Fixation SystemBlackstone Medical, Inc.2002300—
+1K022605Blackstone Spinal Fixation System Staple & WasherBlackstone Medical, Inc.2002302—
+1K022399Blackstone Spinal Fixation System SpacerBlackstone Medical, Inc.2002300—
+2K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+2K170647Connector SystemOrthofix, Inc.201718—
+2K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+2K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+2K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+2K140260Skyhawk Lateral Plate SystemOrthofix, Inc.201414—
+2K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+2K111448Icon (TM) Modular Pedicle Screw SystemOrthofix, Inc.20120—
+2K102204Choice Spine Starfire Pedicle Screw SystemChoicespine, LP201088—
+2K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088—
+2K100044Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone2010117—
+2K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc.20091301
+2K082797Blackstone Pedicle Screw SystemBlackstone Medical, Inc.2008209—
+2K030087Spinal Concepts, Inc. Bacfix TI Spinal SystemSpinal Concepts, Inc.20030—
+2K030667Encore Anterior Spinal Staple SystemEncore Medical L.P.20030—
+3K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+3K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+3K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+3K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+3K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+3K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+3K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+3K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+3K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+3K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+3K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+3K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+3K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+3K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+3K172115Navigated Instrument SystemOrthofix, Inc.20184—
+3K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+3K1721312 Hole Lateral Plating SystemLife Spine, Inc.201710—
+3K172194Connector SystemOrthofix, Inc.2017162
+3K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+3K160362Z-Span Plate SystemZavation, LLC20163—
+3K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+3K150283Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20154—
+3K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+3K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine201482—
+3K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+3K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+3K122901Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix2012116—
+3K111183Ascent Posterior Occipital Thoracic (Poct) System (Titanium & Cobalt Chrome Rods)Orthofix, Inc.201122—
+3K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+4K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+4K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+4K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+4K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+4K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K231658VEOS Spinal Fixation SystemSpineway20230—
+4K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+4K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+4K222789VADER® Pedicle System, G21 CementIcotec AG202352
+4K223273ASTRA Spine SystemSpinecraft, LLC20228—
+4K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+4K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+4K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+4K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+4K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+4K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+4K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+4K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+4K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+4K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+4K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+4K202624Z-Span Plate SystemZavation Medical Products, LLC20201—
+4K200303Reform Pedicle Screw SystemPrecision Spine202010—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+4K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+4K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+4K190751Connector SystemOrthofix, Inc.20193—
+4K182721Choice Spine Navigation SystemChoicespine, LP20192—
+4K181495Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20183—
+4K180166Life Spine Lumbar Fixation System (SENTRY)Life Spine, Inc.20189—
+4K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+4K170942The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP20170—
+4K162824Z-Span Plate SystemZavation, LLC20172—
+4K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+4K161842Overwatch Spine SystemAmendia, Inc.201661
+4K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+4K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP201673—
+4K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—