510(k) Report

Devices descending from K061162

131 later devices reach Bar Pedicle Screw Spinal Fixation System, Model 2020 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc.20091301
+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—
+2K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088—
+2K100044Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone2010117—
+3K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+3K200303Reform Pedicle Screw SystemPrecision Spine202010—
+3K170647Connector SystemOrthofix, Inc.201718—
+3K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+3K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+3K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+3K131833Centurion Poct SystemOrthofix, Inc.20142—
+3K132603Apex Spine SystemSpinecraft, LLC201325—
+3K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+3K130176Firebird Spinal Fixation SystemOrthofix20135—
+4K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+4K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+4K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K240963Spinal SystemTeslake, Inc.20240—
+4K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+4K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+4K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+4K193219G Surgical Marksman SystemG Surgical, LLC20191—
+4K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+4K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+4K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+4K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+4K172194Connector SystemOrthofix, Inc.2017162
+4K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+4K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+4K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+4K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+4K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+4K150417Astra Spine SystemSpinecraft, LLC201521—
+4K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+5K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+5K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+5K233256Robotic Integration InstrumentsDePuy Synthes20240—
+5K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+5K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K223273ASTRA Spine SystemSpinecraft, LLC20228—
+5K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+5K211323ASTRA Spine SystemSpinecraft, LLC202112—
+5K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+5K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+5K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+5K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+5K190751Connector SystemOrthofix, Inc.20193—
+5K172115Navigated Instrument SystemOrthofix, Inc.20184—
+5K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+5K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+5K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+5K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K162786PASS LP Spinal SystemMedicrea International SA20176—
+5K161842Overwatch Spine SystemAmendia, Inc.201661
+5K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+6K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+6K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+6K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+6K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+6K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+6K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+6K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+6K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+6K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+6K220025ARx® Spinal SystemLife Spine, Inc.20220—
+6K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+6K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+6K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+6K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+6K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+6K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+6K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+6K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+6K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+6K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+6K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+6K182240PASS LP Spinal SystemMedicrea International SA20182—
+6K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+6K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+6K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+7K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K252322SIros-X SystemGenesys Spine20250—
+7K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—