510(k) Report

Devices descending from K020522

1,234 later devices reach Modification to Surgical Titanium Mesh System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+4K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+4K160291Optimus ALIF SystemAmendia, Inc.20160—
+4K152568C-VBRCardinal Spine, LLC201657—
+4K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+4K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+4K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+4K152532AERO -C Cervical Cage SystemStryker Spine2015145—
+4K152515TOMCAT Cervical Spinal SystemChoicespine, LP2015108—
+4K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+4K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+4K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+4K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+4K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+4K150481Cascadia Interbody SystemK2m, Inc.20154593
+4K143143Pathway ElifCustom Spine, Inc.201514—
+4K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+4K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+4K142744Mecta-C TiPEEKMedacta International201512—
+4K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+4K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+4K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+4K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+4K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+4K142150Ais Modulift VBR SystemAesculap Implant System, Inc.201447—
+4K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+4K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+4K140563Lateral VBR SystemNu Vasive, Incorporated20140—
+4K140417Divergence Mini-Plate Anterior Cervical Fusion SystemMedtronic Sofamor Danek, Inc.201411—
+4K132999Cervical Stand Alone SystemOrthofix, Inc.2014281—
+4K133614Aleutian Ibf SystemK2m, Inc.2014527—
+4K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+4K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+4K133967Interbody Cage SystemAurora Spine2014227—
+4K133192Mectalif TipeekMedacta International201416—
+4K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+4K133207Staxx (R) SystemSpine Wave, Inc.20131—
+4K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+4K130254Prow FusionNlt Spine, Ltd.20138—
+4K130820Expandable Lumbar Interbody SystemNu Vasive, Incorporated2013593—
+4K130478Sustain and Sustain Radiolucent SpacersGlobus Medical, Inc.2013256—
+4K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314—
+4K130699Aleutian Spinal SystemK2m, Inc.2013570—
+4K124034Mectalif AnteriorMedacta International201311—
+4K123913Latis SpacerGlobus Medical, Inc.201388—
+4K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+4K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+4K123388K7C SpacerK7, LLC20130—
+4K122097Patriot SpacersGlobus Medical, Inc.2012261—
+4K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+4K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+4K121151Pro-Link Cervical Spacer SystemLife Spine, Inc.2012116—
+4K122896Cougar LS 15 Lateral Cage SystemMedos International SARL2012205—
+4K122366Tryptik CC Anterior Intersomatic Cervical CageSpineart20125—
+4K120819Stalif CCentinel Spine, Inc.2012206—
+4K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+4K113540Reliance Lumbar Ibf SystemReliance Medical Systems, LLC201212—
+4K112664Zavation Ibf SystemsZavation, LLC201137—
+4K103382Intercontinental Plate-SpacerGlobus Medical, Inc.2011554—
+4K103729Infill Intervertebral Body Fusion DevicePinnacle Spine Group, LLC201122—
+4K103743Concorde Curve SystemJohnson & Johnson20110—
+4K102293Caliber SpacerGlobus Medical, Inc.2011869—
+4K102313Patriot Transcontinental M SpacersGlobus Medical, Inc.2010361—
+4K101051Avs a-Lat Peek Spacers, Models 48750XXX, 48751XXX, 48752XXX, 48753XXXStryker Spine2010641—
+5K261049Scala® TLSpineart SA20260—
+5K261430TruLift Expandable SystemLife Spine, Inc.20260—
+5K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+5K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+5K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+5K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+5K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+5K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+5K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+5K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+5K250186GoLIF! Lumbar Interbody Fusion SystemGetset Surgical, SA20250—
+5K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+5K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+5K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+5K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+5K242195Gemini Cervical Fusion Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+5K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+5K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+5K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+5K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+5K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+5K240699SCARLET® AC-TiSpineart SA20240—
+5K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+5K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+5K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+5K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+5K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+5K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+5K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+5K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+5K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—