510(k) Report

Devices descending from K962397

531 later devices reach Statak Soft Tissue Attachment Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+8K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+8K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+8K190926Hammertoe Truss System (HTS)4Web, Inc.20193—
+8K183236Rotium Bioresorbable WickNanofiber Solutions, LLC20193—
+8K183331Parcus GFS BTBParcus Medical, LLC20193—
+8K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+8K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+8K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+8K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+8K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+8K172921Stryker Self-Punching ICONIXStryker20170—
+8K160655OrthoButton CLRiverpoint Medical20169—
+8K152711Parcus GFS NakedParcus Medical, LLC20154—
+8K132912Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas201422
+8K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+8K132502Variax 2 SystemStryker Trauma AG201321—
+8K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+9K254280F.A.S.T ScrewSteps Ortho20260—
+9K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+9K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+9K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+9K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+9K254215Arthrex Beaming SystemArthrex, Inc.20261—
+9K252246Leforte MMF SystemJeil Medical Corporation20260—
+9K260448CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20260—
+9K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+9K253618QuadLock™ Fixation SystemAbanza Tecnomed S.L20260—
+9K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+9K250892CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20251—
+9K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO, Ltd.20250—
+9K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+9K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+9K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+9K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+9K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+9K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+9K241912BiochargeNanofiber Solutions, LLC20240—
+9K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+9K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+9K232432E3D™-A Interbody SystemEvolution Spine20248—
+9K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+9K231641Rotium Bioresorbable WickNanofiber Solutions, LLC20231—
+9K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+9K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+9K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+9K222564Treace Medical Concepts (TMC) Hammertoe Fixation SystemTreace Medical Concepts, Inc.20220—
+9K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+9K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+9K220839Arthrex Compression FT PinsArthrex, Inc.20220—
+9K221283Hammertoe Truss System (HTS)4Web Medical, Inc.20222—
+9K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+9K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+9K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+9K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+9K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+9K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+9K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+9K201414Rotium Bioresorbable WickNanofiber Solutions, LLC20202—
+9K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+9K173556Injection ScrewBiedermann Medtech, Inc.20180—
+9K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+9K171060OrthoButton ALRiverpoint Medical20178—
+9K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+9K140769Variax 2 SystemStryker Trauma AG201419—
+10K262975Arthrex Beaming SystemArthrex, Inc.20260—
+10K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+10K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+10K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+10K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+10K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+10K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+10K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+10K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+10K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+10K241846E3D™-C Interbody SystemEvolution Spine20246—
+10K240835Suture Button Repair SystemSkeletal Dynamics, Inc.20241—
+10K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+10K240368E3D™-A Interbody SystemEvolution Spine20247—
+10K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+10K240194ProCinch, QuadCinchRiverpoint Medical20240—
+10K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20241—
+10K233552IDEAL ZiploopRiverpoint Medical20230—
+10K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+10K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+10K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+10K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+10K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+10K230212OrthoButton ALRiverpoint Medical, LLC20232—
+10K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+10K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+10K202399OrthoButton FLRiverpoint Medical20201—
+10K173135VariAx 2 SystemStryker GmbH201713—
+10K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+11K261770Suture Button Repair SystemSkeletal Dynamics, Inc.20260—
+11K262094E3D™-C Interbody SystemEvolution Spine20260—
+11K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+11K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+11K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+11K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—