510(k) Report

Devices descending from K153428

73 later devices reach Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172115Navigated Instrument SystemOrthofix, Inc.20184—
+1K170647Connector SystemOrthofix, Inc.201718—
+1K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+2K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+2K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+2K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+2K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+2K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+2K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+2K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+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—
+2K172194Connector SystemOrthofix, Inc.2017162
+3K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+3K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+3K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+3K231658VEOS Spinal Fixation SystemSpineway20230—
+3K223273ASTRA Spine SystemSpinecraft, LLC20228—
+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—
+3K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+3K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+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—
+3K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+3K190751Connector SystemOrthofix, Inc.20193—
+4K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+4K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+4K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+4K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+4K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+4K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+4K233256Robotic Integration InstrumentsDePuy Synthes20240—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+4K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+4K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+4K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+4K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K252322SIros-X SystemGenesys Spine20250—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+5K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+5K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+5K233366SYMPHONY OCT SystemMedos International SARL20230—
+5K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+5K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+6K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—