510(k) Report

Devices descending from K003275

1,705 later devices reach Synthes Synmesh Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+4K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+4K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+4K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+4K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+4K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+4K161129Pillar SA PTCOrthofix, Inc.201619—
+4K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+4K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+4K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+4K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+4K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+4K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+4K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+4K143490VERTA Corpectomy CageCamber Spine20151—
+4K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+4K133827A-Link ZOsteo Vasive, LLC2014262
+4K142150Ais Modulift VBR SystemAesculap Implant System, Inc.201447—
+4K140563Lateral VBR SystemNu Vasive, Incorporated20140—
+4K132907Plif Lite and Tlif LiteSintea Plustek20140—
+4K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+4K132999Cervical Stand Alone SystemOrthofix, Inc.2014281—
+4K132596Proposed OptimusCustom Spine, Inc.201451
+4K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+4K133455Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc.20145961
+4K133529Camber Spine Coveris Cervical CageCamber Spine201410—
+4K133623C-PLUSPioneer Surgical Technology, Inc.2014598—
+4K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+4K123758Tasmin RSignus Medizintechnik GmbH20141—
+4K132718Integrity Spine Core SystemIntegrity Spine20131—
+4K131077Life Spine Plateau Spacer SystemLife Spine201310—
+4K124034Mectalif AnteriorMedacta International201311—
+4K123206Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical2013454—
+4K123388K7C SpacerK7, LLC20130—
+4K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+4K122444Cervical CageEisertech, LLC201222—
+4K121103LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior Spinal…Ldr Spine USA, Inc.201216—
+4K120570Choice Spine Vertebral Body Replacement (VBR) Device SystemChoicespine, LP2012322—
+4K112429Giza (R) Vertebral Body ReplacementEden Spine, LLC201221
+4K112496Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc.2011604—
+4K110659Medical Concepts Interbody Fusion SystemMedical Concepts, Inc.20111—
+4K111626Endoskeleton (R) TasTitan Spine, LLC2011273—
+4K102315Staxx XDL SystemSpine Wave, Inc.20113—
+4K111469Staxxsd SystemSpine Wave, Inc.20110—
+4K110650Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC)2011177—
+4K110864Biospine VBR SystemAesculap Implant Systems, LLC201149—
+4K103034Genesys Spine Interbody Fusion SystemGenesys Spine20101371
+4K100042Difusion Technologies Xiphos Interbody Fusion SystemDifusion Technologies2010864—
+4K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2010480—
+4K100043Coroent XLR Standalone SystemNuvasive, Inc.2010744—
+4K092774Atlas Intervertebral Body CageSpinal Edge, LLC20100—
+4K092540C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody SpacerRsb Spine, LLC201045—
+4K092904Pathway Ivb/VBRCustom Spine, Inc.2009296—
+4K091301Life Spine Stand-Alone Spacer SystemLife Spine2009473—
+4K090315Staxx XD SystemSpine Wave, Inc.20096—
+4K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA2009901—
+4K083815Lanx Fusion SystemLanx, Inc.2009451—
+4K083714Endoskeleton TT Interbody Fusion Device (Ibd)Titan Spine, LLC2009412—
+4K090064Eminent Spine Interbody Fusion SystemEminent Spine20097011
+4K083857LDR Spine Roi-C ImplantLdr Spine USA2009902—
+4K080971Spinesmith Cimplicity Spinal SystemSpine Smith Partners L.P.2008406—
+4K072326Ostapek VBR SystemCo-Ligne AG20081—
+4K080728LDR Spine Roi-C ImplantLdr Spine USA2008903—
+4K080860Creaspine Supstance Small Vertebral Body Replacement SystemCreaspine20080—
+4K080569LDR Spine Roi-T ImplantLdr Spine USA20080—
+4K080572LDR Spine Roi-a ImplantLdr Spine USA2008113—
+4K072132LDR Spine Roi-T SystemLdr Spine USA20071—
+4K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.20071,406—
+4K060762Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc.2006789—
+4K061836Avs Asl Peek Spacer SystemStryker Spine2006213—
+4K061151Pioneer Vertebral Spacer (Vertebral Spacer)Pioneer Surgical Technology2006801—
+4K051454Aleutian Spacer SystemK2m, LLC2005666—
+4K043405Nuvasive Coroent SystemNuvasive, Inc.20057121
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K261049Scala® TLSpineart SA20260—
+5K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+5K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+5K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+5K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+5K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+5K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+5K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+5K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+5K260660SABER-C SystemElevation Spine20261—
+5K253260ORIO-3D Cage SystemSpineCraft20260—
+5K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+5K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+5K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+5K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+5K250540SABER-C SystemElevation Spine20252—
+5K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+5K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+5K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+5K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+5K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+5K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+5K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—