510(k) Report

Devices descending from K022285

403 later devices reach Modification to Isola Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+6K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+6K151216Everest Spinal SystemK2m, Inc.201511—
+6K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+6K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+6K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+6K133369Tiger Spine SystemCorelink, LLC201429—
+6K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+6K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+6K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+6K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+7K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+7K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+7K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+7K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+7K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+7K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+7K231658VEOS Spinal Fixation SystemSpineway20230—
+7K223273ASTRA Spine SystemSpinecraft, LLC20228—
+7K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+7K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+7K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+7K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+7K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+7K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+7K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+7K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+7K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+7K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+7K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+7K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+7K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+7K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+7K193219G Surgical Marksman SystemG Surgical, LLC20191—
+7K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+7K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+7K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+7K190751Connector SystemOrthofix, Inc.20193—
+7K190376PASS LP Spinal SystemMedicrea International SA201915
+7K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+7K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+7K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+7K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+7K171651Excelsius GPSGlobus Medical, Inc.2017691
+7K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+7K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+7K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+7K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+7K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+7K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+7K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+7K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+7K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+7K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+8K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+8K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+8K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+8K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+8K241525ExcelsiusXR™Globus Medical, Inc.20250—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+8K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+8K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+8K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+8K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+8K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+8K240160EGPS Navigated InstrumentsAstura Medical20240—
+8K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+8K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+8K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+8K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+8K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+8K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+8K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+8K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+8K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+8K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+8K223558CUVIS-spineCurexo, Inc.20230—
+8K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+8K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+8K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+8K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232