510(k) Report

Devices descending from K963172

722 later devices reach Synthes Sterile 4.5 MM Cannulated Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+6K250424Arthrex TightRope Soft Button, RTArthrex, Inc.20250—
+6K243624Acu-Sinch Knotless MiniAcumed, LLC20250—
+6K242494OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel ConstructRiverpoint Medical, LLC20240—
+6K240487EVOS Patella PlatesSmith & Nephew20240—
+6K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+6K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+6K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+6K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+6K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+6K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+6K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+6K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+6K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+6K232411JuggerKnot Soft Anchor OCRiverpoint Medical, LLC20232—
+6K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+6K232324StealthFix Intraosseous Fixation SystemMedartis, Inc.20230—
+6K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+6K230329F3D Interbody SystemCorelink, LLC20230—
+6K231128JuggerKnot Soft AnchorRiverpoint Medical, LLC20230—
+6K230544SnugFit All-Suture Anchor extensionMedacta International S.A.20231—
+6K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+6K222574Simparo Anchor Line Fixation SystemSimparo, Inc.20230—
+6K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+6K223795FairFix QT Adjustable ButtonMedacta International S.A.20230—
+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—
+6K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+6K221283Hammertoe Truss System (HTS)4Web Medical, Inc.20222—
+6K222169FairFix Adjustable Button SystemMedacta International S.A.20220—
+6K221389FairFix AM Adjustable Button FairFix PSP Adjustable ButtonMedacta International S.A.20220—
+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—
+6K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+6K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+6K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+6K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+6K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+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—
+6K192441Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+6K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+6K190516MicroLink All-Suture Button Fixation System (Radiolucent)Conmed Corporation20190—
+6K190582MicroLink All-Suture Button Fixation System (Radiopaque)Conmed Corporation20190—
+6K191226Arthrex SwiveLock Suture AnchorArthrex, Inc.201921—
+6K183331Parcus GFS BTBParcus Medical, LLC20193—
+6K173556Injection ScrewBiedermann Medtech, Inc.20180—
+6K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+6K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+6K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+6K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+6K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+6K160655OrthoButton CLRiverpoint Medical20169—
+6K152711Parcus GFS NakedParcus Medical, LLC20154—
+6K140769Variax 2 SystemStryker Trauma AG201419—
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+7K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+7K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+7K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+7K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+7K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+7K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+7K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+7K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+7K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+7K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+7K251309OSSIOfiber® Suture AnchorOSSIO, Ltd.20251—
+7K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+7K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+7K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+7K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+7K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+7K243203OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft AnchorRiverpoint Medical20240—
+7K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+7K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+7K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+7K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+7K240719OC JuggerKnot Soft AnchorRiverpoint Medical20240—
+7K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, 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—
+7K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+7K221578Hexanium ACIFSpinevision, S.A.S.20224—