510(k) Report

Devices descending from K072253

1,250 later devices reach Synfix-LR Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+4K251016MectaLIF 3D MetalMedacta International S.A.20250—
+4K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+4K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+4K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+4K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+4K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+4K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+4K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+4K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+4K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+4K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+4K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+4K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+4K250556Porous Biologic ScaffoldVentris Medical20250—
+4K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+4K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+4K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+4K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+4K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+4K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+4K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+4K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K242589Scarlet® AL-TSpineart SA20240—
+4K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+4K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+4K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+4K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+4K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+4K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+4K241438Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH20240—
+4K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+4K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+4K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+4K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+4K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+4K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+4K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+4K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+4K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+4K240368E3D™-A Interbody SystemEvolution Spine20247—
+4K240699SCARLET® AC-TiSpineart SA20240—
+4K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+4K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+4K240442MagnetOs PuttyKuros Biosciences B.V20243—
+4K240715Idys® C ZP 3DTiClariance20240—
+4K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+4K240458Synthetic Bone PuttyVentris Medical20242—
+4K233075“BioGend” Interbody Fusion System 001 CageBiogend Therapeutics Co., Ltd.20240—
+4K240459Cerament Bone Void FillerBonesupport AB20240—
+4K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+4K232347MagnetOs GranulesKuros Biosciences B.V20242—
+4K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+4K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+4K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+4K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+4K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+4K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+4K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+4K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+4K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+4K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+4K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+4K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+4K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+4K232315Catalyst Bone Void FillerOssdsign AB20237—
+4K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+4K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+4K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+4K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+4K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+4K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+4K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+4K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+4K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+4K230329F3D Interbody SystemCorelink, LLC20230—
+4K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+4K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+4K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+4K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+4K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+4K230026SqualeImplanet, S.A.20230—
+4K230583Tryptik TiSpineart SA20231—
+4K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+4K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+4K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+4K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+4K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+4K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+4K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+4K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+4K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+4K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—