510(k) Report

Devices descending from K071668

582 later devices reach Orthobiom Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K161016Z-Clamp ISP SystemZavation, LLC20160—
+4K161842Overwatch Spine SystemAmendia, Inc.201661
+4K160698LigaPASSMedicrea International SA201612—
+4K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+4K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc.20160—
+4K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+4K161265NuVasive® VersaTie SystemNu Vasive, Incorporated20163—
+4K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+4K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+4K160568Precision Spine Interspinous Plate SystemPrecision Spine, Inc.20160—
+4K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+4K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+4K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+4K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+4K151740JAZZ SystemImplanet, S.A.201512—
+4K151741HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC20158—
+4K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+4K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+4K143759JAZZ SystemImplanet, S.A.201513—
+4K142217Reliance Interspinous Plate SystemReliance Medical Systems, LLC20150—
+4K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+4K142360Everest Spinal SystemK2m, Inc.201522—
+4K142378Interspinous Plate SystemPrecision Spine, Inc.20143—
+4K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+4K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+4K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+4K133617Jazz SystemImplanet, S.A.201414—
+4K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+4K132968Univise Spinous Process Fixation Plate (35MM, 40MM)Stryker Spine201312—
+4K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+4K123138Pass LP Spinal SystemMedicrea International2013132—
+4K120838Synthes Matrix SystemSynthes Spine201216—
+4K120928Synthes Matrix SystemSynthes Spine20120—
+4K120571Synthes Uss ConnectorSynthes Spine201274—
+5K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+5K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+5K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+5K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+5K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+5K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K252322SIros-X SystemGenesys Spine20250—
+5K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+5K253331PressON Spinal Fixation SystemNexus Spine20250—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K252437JAZZ Spinal SystemImplanet20250—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+5K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+5K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+5K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+5K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+5K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+5K233256Robotic Integration InstrumentsDePuy Synthes20240—
+5K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+5K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+5K241258Ingenix Spinal SystemIngenium Spine20240—
+5K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+5K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+5K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+5K233300POWEReam 1/4 DriveStryker Instruments20231—
+5K231515MySpine Cervical GuidesMedacta International S.A.20230—
+5K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+5K233527Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion…Spinal Simplicity, LLC20232—
+5K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+5K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+5K231479TriALTIS Spine SystemMedos International SARL20238—
+5K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+5K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+5K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+5K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+5K222698CUVIS-spineCurexo, Inc.20220—
+5K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+5K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+5K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K211880Minuteman G5 MIS Fusion PlateSpinal Simplicity, LLC20224—
+5K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+5K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+5K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+5K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+5K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+5K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+5K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+5K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+5K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—