510(k) Report

Devices descending from K022623

294 later devices reach 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+6K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+6K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+6K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+6K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+6K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+6K172194Connector SystemOrthofix, Inc.2017162
+6K151216Everest Spinal SystemK2m, Inc.201511—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+7K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+7K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+7K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+7K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+7K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+7K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+7K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+7K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+7K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+7K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+7K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+7K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+7K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+7K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+7K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+7K231658VEOS Spinal Fixation SystemSpineway20230—
+7K230026SqualeImplanet, S.A.20230—
+7K223273ASTRA Spine SystemSpinecraft, LLC20228—
+7K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+7K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+7K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+7K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+7K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+7K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+7K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+7K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+7K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+7K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+7K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+7K190751Connector SystemOrthofix, Inc.20193—
+8K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+8K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+8K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+8K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+8K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+8K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+8K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+8K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+8K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+8K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K233256Robotic Integration InstrumentsDePuy Synthes20240—
+8K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+8K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K220025ARx® Spinal SystemLife Spine, Inc.20220—
+8K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+8K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+8K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+8K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+9K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+9K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+9K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+9K252322SIros-X SystemGenesys Spine20250—
+9K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K233366SYMPHONY OCT SystemMedos International SARL20230—
+9K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+9K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—