510(k) Report

Devices descending from K052054

786 later devices reach TSRH Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+5K181980OsseoScrew SystemAlphatec Spine, Inc.20181—
+5K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+5K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+5K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+5K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+5K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+5K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+5K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+5K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+5K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+5K180433Ennovate®Aesculap Implant Systems, LLC201811
+5K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+5K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+5K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+5K180324Patriot Spinal Fixation SystemValorus Spine20180—
+5K180376K2M Patient Specific RodsK2m, Inc.20182—
+5K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+5K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+5K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+5K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+5K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+5K173095VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with…Medos International SARL201719—
+5K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+5K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+5K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+5K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+5K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+5K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+5K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+5K170543VIPER PRIME™ Screws with FenestrationsMedos International SARL201748—
+5K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+5K170964Zenius Spinal SystemMedyssey USA, Inc.20170—
+5K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+5K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+5K162764Jazz Frame SystemImplanet, S.A.20176—
+5K160640PASS XS Spinal SystemMedicrea International SA20160—
+5K161369EVEREST Spinal SystemK2m, Incorporated20169—
+5K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+5K160926F1 MPS Modular Pedicle Screw SystemDegen Medical20161—
+5K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+5K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+5K153413PASS LP Spinal SystemMedicrea International SA20160—
+5K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+5K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+5K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+5K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+5K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+5K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+5K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+5K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+5K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+5K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+5K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+5K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+5K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+5K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584—
+5K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+5K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+5K142499Reline SystemNu Vasive, Incorporated201478—
+5K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+5K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+5K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+5K132361Everest Spinal SystemK2m, Inc.201334—
+5K130302Spinevision Lumis Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…Spinevision S.A.20134—
+5K113058Tiger Spine SystemCorelink, LLC201281—
+6K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+6K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+6K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+6K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+6K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+6K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+6K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K253249TriALTIS™ Spine SystemMedos International SARL20251—
+6K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+6K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+6K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+6K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+6K243249TriALTIS™ Spine SystemMedos International SARL20250—
+6K243693NEO Pedicle Screw System™Neo Medical SA20240—
+6K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K233256Robotic Integration InstrumentsDePuy Synthes20240—
+6K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+6K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+6K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+6K233300POWEReam 1/4 DriveStryker Instruments20231—
+6K233684TriALTIS™ Spine SystemMedos International SARL20234—
+6K231515MySpine Cervical GuidesMedacta International S.A.20230—
+6K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—