510(k) Report

Devices descending from K072981

546 later devices reach Synthes Zero-P through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+5K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+5K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+5K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+5K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+5K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+5K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+5K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+5K230026SqualeImplanet, S.A.20230—
+5K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+5K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+5K223494CD Horizon Spinal SystemMedtronic202317—
+5K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+5K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+5K212612Omnia Medical TiBrid-SCOmnia Medical, LLC20220—
+5K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+5K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+5K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+5K221172FOCUS Interbody SystemOc Medical Devices20220—
+5K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+5K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+5K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+5K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+5K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+5K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+5K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+5K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+5K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+5K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+5K203444BEE HA CageNGMedical GmbH20211—
+5K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+5K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+5K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+5K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+5K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+5K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+5K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+5K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+5K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+5K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+5K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+5K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+5K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+5K190655SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201974—
+5K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+5K182477Cervical SpacerAdditive Implants, LLC201915—
+5K171312FortiCore®Nanovis, LLC20183—
+5K171140Matrixx SystemNexxt Spine, LLC2017145—
+5K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+5K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+5K170055CAPRI Corpectomy Cage SystemK2m201711—
+5K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+5K163364MOJAVE Expandable Interbody SystemK2m201725—
+5K162264Cascadia Interbody SystemK2m, Inc.2016169—
+5K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+5K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+6K261408SABER-XA SystemElevation Spine20260—
+6K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+6K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+6K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+6K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+6K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+6K253331PressON Spinal Fixation SystemNexus Spine20250—
+6K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+6K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+6K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+6K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+6K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+6K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+6K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+6K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+6K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+6K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+6K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+6K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+6K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+6K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+6K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+6K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+6K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+6K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+6K232123MectaLIF Anterior Lag ExtensionMedacta International S.A.20231—
+6K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+6K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+6K223326Axiom PSR SystemRestor3D202301
+6K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+6K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—