510(k) Report

Devices descending from K100044

117 later devices reach Firebird Spinal Fixation System, Firebird Side-Loading Body through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+1K122901Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix2012116—
+2K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+2K200303Reform Pedicle Screw SystemPrecision Spine202010—
+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—
+2K132603Apex Spine SystemSpinecraft, LLC201325—
+2K130176Firebird Spinal Fixation SystemOrthofix20135—
+3K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+3K240963Spinal SystemTeslake, Inc.20240—
+3K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+3K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+3K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+3K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+3K193219G Surgical Marksman SystemG Surgical, LLC20191—
+3K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+3K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+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
+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—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+4K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+4K233256Robotic Integration InstrumentsDePuy Synthes20240—
+4K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+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—
+4K211323ASTRA Spine SystemSpinecraft, LLC202112—
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+4K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+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—
+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—
+4K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+4K172194Connector SystemOrthofix, Inc.2017162
+4K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+4K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K162786PASS LP Spinal SystemMedicrea International SA20176—
+4K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+5K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+5K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+5K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+5K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+5K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+5K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+5K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+5K231658VEOS Spinal Fixation SystemSpineway20230—
+5K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+5K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+5K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+5K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+5K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+5K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+5K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+5K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+5K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+5K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+5K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+5K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+5K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+5K190751Connector SystemOrthofix, Inc.20193—
+5K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+5K182240PASS LP Spinal SystemMedicrea International SA20182—
+5K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+6K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+6K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+6K252322SIros-X SystemGenesys Spine20250—
+6K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+6K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+6K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+6K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+6K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+6K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—