510(k) Report

Devices descending from K113642

292 later devices reach Perimeter Interbody Fusion Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+1K131669Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.2013234—
+1K121982Sovereign Spinal SystemMedtronic Sofamor Danek2012155—
+2K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+2K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+2K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+2K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+2K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+2K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+2K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+2K140709Skyhawk Interbody Fusion SystemOrthofix, Inc.20147—
+2K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+3K261408SABER-XA SystemElevation Spine20260—
+3K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+3K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+3K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+3K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+3K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+3K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+3K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+3K180695FBC 921 (Alif)Fbc Device Aps20180—
+3K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+3K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+3K172083Idys™ ALIF SystemClariance, Sas20177—
+3K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+3K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+3K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+3K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+3K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+3K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+3K161379ELSA SpacersGlobus Medical, Inc.2016155—
+3K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+4K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+4K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+4K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+4K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+4K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+4K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+4K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+4K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+4K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+4K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+4K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+4K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+4K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+4K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+4K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+4K201671A-Link ZAcuity Surgical Devices, LLC202125—
+4K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+4K200919Idys ALIF 3DTiClariance20210—
+4K202032Idys LLIF 3DTiClariance, Sas20210—
+4K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+4K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+4K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+4K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+4K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+4K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+4K191134IB3D AlifMedicrea International SA20191—
+4K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K191263Idys ALIF TiVacClariance, Sas20190—
+4K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+4K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+4K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+4K181397DualXInnovasive, Inc.201815—
+4K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+4K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+4K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+4K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+4K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+5K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+5K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+5K252742Navigated InstrumentsTyber Medical, LLC20251—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K241525ExcelsiusXR™Globus Medical, Inc.20250—
+5K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+5K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+5K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+5K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+5K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+5K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+5K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+5K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+5K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+5K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+5K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+5K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+5K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+5K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+5K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+5K223326Axiom PSR SystemRestor3D202301