510(k) Report

Devices descending from K011830

582 later devices reach Tri-Fix Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+9K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+9K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+10K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+10K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+10K262094E3D™-C Interbody SystemEvolution Spine20260—
+10K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+10K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+10K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+10K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+10K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+10K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+10K260038E3D™-C Interbody SystemEvolution Spine20261—
+10K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+10K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+10K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+10K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+10K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+10K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+10K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+10K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+10K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+10K243693NEO Pedicle Screw System™Neo Medical SA20240—
+10K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+10K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+10K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+10K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+10K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+10K232432E3D™-A Interbody SystemEvolution Spine20248—
+10K233684TriALTIS™ Spine SystemMedos International SARL20234—
+10K233366SYMPHONY OCT SystemMedos International SARL20230—
+10K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+10K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+10K223494CD Horizon Spinal SystemMedtronic202317—
+10K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+10K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+10K181188EVEREST Spinal SystemK2m, Inc.20186—
+10K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+10K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+10K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+10K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+10K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+10K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+11K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+11K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+11K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+11K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+11K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+11K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+11K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+11K253331PressON Spinal Fixation SystemNexus Spine20250—
+11K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+11K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+11K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+11K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+11K242042TriALTIS™ Spine SystemMedos International SARL20241—
+11K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+11K240368E3D™-A Interbody SystemEvolution Spine20247—
+11K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+11K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+11K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+11K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+11K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+11K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+11K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+11K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+11K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+11K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+11K182470Plateau Spacer SystemLife Spine20180—
+11K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+12K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+12K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+12K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+12K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+12K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+12K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+12K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+12K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+13K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+14K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+14K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+14K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—