510(k) Report

Devices descending from K021932

755 later devices reach Synthes 6.5 MM Cannulated Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+6K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+6K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+6K252246Leforte MMF SystemJeil Medical Corporation20260—
+6K242303MOD-COrthomod, LLC20260—
+6K252961Fusion FibFix NailFusion Orthopedics USA, LLC20260—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+6K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+6K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+6K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…Arthrex, Inc.20250—
+6K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+6K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.20250—
+6K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+6K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+6K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+6K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+6K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+6K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+6K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+6K230329F3D Interbody SystemCorelink, LLC20230—
+6K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+6K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+6K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+6K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+6K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+6K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+6K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+6K212358Romero Cervical CageSpineup, Inc.20226—
+6K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+6K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+6K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+6K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+6K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+6K210667FIREBIRD SI Fusion SystemOrthofix, Inc.202119—
+6K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+6K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+6K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+6K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+6K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+6K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+6K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+6K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+6K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+6K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+6K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+6K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+6K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+6K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+7K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+7K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+7K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+7K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+7K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+7K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+7K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+7K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+7K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+7K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+7K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+7K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+7K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+7K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+7K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+7K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+7K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+7K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+7K230026SqualeImplanet, S.A.20230—
+7K221578Hexanium ACIFSpinevision, S.A.S.20224—
+7K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+7K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+7K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+7K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+7K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+7K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+7K211306LabyrinthZavation Medical Products, LLC20213—
+7K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+7K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+7K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—