510(k) Report

Devices descending from K171082

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+1K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+1K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+1K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+1K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+1K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+2K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+2K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+2K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+2K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+2K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+2K231658VEOS Spinal Fixation SystemSpineway20230—
+2K223273ASTRA Spine SystemSpinecraft, LLC20228—
+2K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+2K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+2K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+2K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+2K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+2K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+2K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+2K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+2K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+2K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+2K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+2K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+3K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+3K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+3K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+3K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+3K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+3K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+3K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+3K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+3K233256Robotic Integration InstrumentsDePuy Synthes20240—
+3K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+3K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+3K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+3K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+3K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+3K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+3K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+3K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+3K220025ARx® Spinal SystemLife Spine, Inc.20220—
+3K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+3K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+3K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+3K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+4K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+4K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+4K252322SIros-X SystemGenesys Spine20250—
+4K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+4K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+4K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+4K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+4K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+5K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—