510(k) Report

Devices descending from K080407

296 later devices reach Blackstone SFS Parallel Rod Connectors through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+1K170647Connector SystemOrthofix, Inc.201718—
+1K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+1K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+1K140260Skyhawk Lateral Plate SystemOrthofix, Inc.201414—
+1K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088—
+1K100044Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone2010117—
+1K081684Blackstone Pedicle Screw SystemBlackstone Medical, Inc.20082773
+2K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+2K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+2K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+2K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+2K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+2K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+2K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+2K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+2K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+2K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+2K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+2K1721312 Hole Lateral Plating SystemLife Spine, Inc.201710—
+2K172194Connector SystemOrthofix, Inc.2017162
+2K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+2K160362Z-Span Plate SystemZavation, LLC20163—
+2K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+2K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+2K122901Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix2012116—
+2K111448Icon (TM) Modular Pedicle Screw SystemOrthofix, Inc.20120—
+2K102204Choice Spine Starfire Pedicle Screw SystemChoicespine, LP201088—
+2K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc.20091301
+2K082797Blackstone Pedicle Screw SystemBlackstone Medical, Inc.2008209—
+3K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+3K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+3K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+3K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+3K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+3K231658VEOS Spinal Fixation SystemSpineway20230—
+3K223273ASTRA Spine SystemSpinecraft, LLC20228—
+3K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+3K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+3K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+3K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+3K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+3K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+3K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+3K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+3K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+3K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+3K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+3K202624Z-Span Plate SystemZavation Medical Products, LLC20201—
+3K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+3K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+3K200303Reform Pedicle Screw SystemPrecision Spine202010—
+3K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+3K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+3K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+3K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+3K190751Connector SystemOrthofix, Inc.20193—
+3K180166Life Spine Lumbar Fixation System (SENTRY)Life Spine, Inc.20189—
+3K162824Z-Span Plate SystemZavation, LLC20172—
+3K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+3K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+3K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+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—
+3K132603Apex Spine SystemSpinecraft, LLC201325—
+3K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+3K130176Firebird Spinal Fixation SystemOrthofix20135—
+3K111183Ascent Posterior Occipital Thoracic (Poct) System (Titanium & Cobalt Chrome Rods)Orthofix, Inc.201122—
+3K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+4K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+4K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+4K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+4K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+4K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+4K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+4K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+4K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+4K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+4K233256Robotic Integration InstrumentsDePuy Synthes20240—
+4K240963Spinal SystemTeslake, Inc.20240—
+4K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+4K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+4K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+4K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+4K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—