510(k) Report

Devices descending from K010673

292 later devices reach Arthrex Fiberwire, Model Spu-02NB-3800 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K221389FairFix AM Adjustable Button FairFix PSP Adjustable ButtonMedacta International S.A.20220—
+5K220650TriMed Ripcord DeviceTriMed, Inc.202211
+5K220260Hercules Syndesmosis Implant SystemIn2bones USA, LLC20220—
+5K211770R3ACT Stabilization SystemParagon 28, Inc.20213—
+5K212739ActiFlipParcus Medical, LLC20210—
+5K203121Responsive Arthroscopy Thunderbolt SystemResponsive Arthroscopy, LLC20211—
+5K210078Stryker ProCinch Adjustable Loop DeviceStryker Endoscopy20210—
+5K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…Parcus Medical, LLC20202—
+5K202193PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP…S.B.M. Sas (Science & Bio Materials)20201—
+5K200028Coronet Soft Tissue Fixation SystemConextions Medical20202—
+5K192637High Strength SutureYunyi (Beijing) Medical Device Co., Ltd.20200—
+5K193165MectaFix CL Fixation Button with Continuous LoopMedacta International S.A.20200—
+5K192441Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+5K190516MicroLink All-Suture Button Fixation System (Radiolucent)Conmed Corporation20190—
+5K190582MicroLink All-Suture Button Fixation System (Radiopaque)Conmed Corporation20190—
+5K191226Arthrex SwiveLock Suture AnchorArthrex, Inc.201921—
+5K180759SECULOK™ Suture AnchorU&I Corporation20180—
+5K181772NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0)Ceterix Orthopaedics, Inc.20180—
+5K173278ToggleLoc SystemBiomet, Inc.20183—
+5K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC20170—
+5K162198GFS UltimateParcus Medical, LLC20168—
+5K162310XBraid TT Suture TapeStryker20161—
+5K153186Adjustable Fixation DeviceArthrocare Corp.20161—
+5K151068SureLock W Suture AnchorCayenne Medical, Inc.20156—
+5K143092Tensyn PlugDallen Medical, Inc.20151—
+5K143172ACL SMART SystemSmith & Nephew, Inc.20150—
+5K141263Toggleloc and Juggerloc Implants/Instruments/KitsBiomet Manufacturing Corp201402
+5K142653G-Lok and G-Lok XL ExtenderT.A.G. Medical Products Corporation, Ltd.20140—
+5K140643Gryphon BR Anchor W/Proknot Technology,Gryphon Peek Anchor W/ Proknot TechnologyDepuy Mitek, A Johnson and Johnson Company20140—
+5K140324Rigidloop Adjustable Cortical Implant: Standard, Long and XLDepuy Mitek, A Johnson and Johnson Company20140—
+5K133579Multifilament Stainless Steel Sutures with CrimpsPontis Orthopaedics, LLC20140—
+5K141259Gryphon BR Anchor with Permacord, Gryphon BR DS Anchor with Permacord,Gryphon Peek…Depuy Mitek, A Johnson & Johnson Company20141—
+5K133606N8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral Implant, N8TIVE Acl Tibial…ArthroCare Corporation20142—
+5K133757GFS II Standard, GFS II Large, GFS MimiParcus Medical, LLC201416—
+5K133727Q-Fix Suture Anchor, 1.8MM; Q-Fix Suture Anchor, 2.8MM; Drill, Drill Guide and…ArthroCare Corporation20145—
+5K132241Gryphon BR Anchor W/ Proknot Technology, Gryphon BR Anchor W/ Proknot Technology - Hip…Depuy Mitek, A Johnson & Johnson Company20131—
+5K130105Rigidfix Curve ST Acl Pla Cross Pin System, Rigidfix Curve ST Acl Peek Cross Pin SystemDepuy Mitek, A Johnson & Johnson Company20130—
+5K113534Healix Knotless AnchorDepuy Mitek, A Johnson & Johnson Company20110—
+6K261632Thunderbolt SystemResponsive Arthroscopy, Inc.20260—
+6K252201HS FiberRiverpoint Medical20250—
+6K251310OTS 25-L (100-5)Ots Medical, Ltd.20250—
+6K251309OSSIOfiber® Suture AnchorOSSIO, Ltd.20251—
+6K243203OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft AnchorRiverpoint Medical20240—
+6K240035TACTIX Vector Syndesmosis SystemVilex, LLC20241—
+6K241235Arthrex TightRope IIArthrex, Inc.20243—
+6K240719OC JuggerKnot Soft AnchorRiverpoint Medical20240—
+6K220966SinefixBAAT Medical Products B.V.20231—
+6K222971ULTRABUTTON QUAD Adjustable Fixation Device; ULTRABUTTON BB Adjustable Fixation Device…Smith & Nephew, Inc.20230—
+6K213018Auxilock GFS Mini, GFS II Large, and GFS UltimateAuxein Medical Private Limited20220—
+6K222263Arthrex Self Punching SwiveLock Suture AnchorsArthrex, Inc.20220—
+6K211502Alpha Vent PEEK Suture AnchorStryker Endoscopy20211—
+6K203495Arthrex SwiveLock AnchorArthrex, Inc.2021131
+6K193503Arthrex SwiveLock Suture AnchorArthrex, Inc.20204—
+6K191783Parcus Synd-EZ TiParcus Medical, LLC20195—
+6K183331Parcus GFS BTBParcus Medical, LLC20193—
+6K181809GRYPHON® Anchors with DYNACORD™ SutureMedos International SARL20180—
+6K172186BioWick X Implant with DriverCayenne Medical, Inc.20174—
+6K172165Q-Fix Suture AnchorArthroCare Corporation20174—
+6K160655OrthoButton CLRiverpoint Medical20169—
+6K152711Parcus GFS NakedParcus Medical, LLC20154—
+6K150359Tensyn PlugDallen Medical, Inc.20150—
+7K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE…Smith & Nephew, Inc.20260—
+7K254176SinefixBAAT Medical Products B.V.20260—
+7K253695LigaMendRiverpoint Medical, LLC20260—
+7K254055OSSIOfiber® Suture AnchorOSSIO, Ltd.20260—
+7K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorStryker Endoscopy20250—
+7K243988RootMend MRRRiverpoint Medical, LLC20250—
+7K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L20251—
+7K243408TACTIX Vector Syndesmosis SystemVilex, LLC20240—
+7K241435Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX…Smith & Nephew, Inc.20241—
+7K233893AlphaVent Knotless SP PEEK AnchorStryker Endoscopy20241—
+7K232457Q-FIX ULTRA All-Suture AnchorSmith & Nephew20230—
+7K231093AlphaVent Suture AnchorsStryker Endoscopy20230—
+7K231376Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape)Smith & Nephew, Inc.20230—
+7K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture…Suzhou Endophix Co., Ltd.20230—
+7K230435Arthrex 3.9 mm SwiveLock AnchorArthrex, Inc.20231—
+7K221502Parcus Synd-EZ SSParcus Medical, LLC20220—
+7K213415OSSIOfiber Suture AnchorOSSIO, Ltd.20223—
+7K192964Parcus Synd-EZ SSParcus Medical, LLC20191—
+7K183236Rotium Bioresorbable WickNanofiber Solutions, LLC20193—
+7K171060OrthoButton ALRiverpoint Medical20178—
+8K253618QuadLock™ Fixation SystemAbanza Tecnomed S.L20260—
+8K243760OSSIOfiber® Suture Anchor 2.5-3.5 mmOSSIO, Ltd.20250—
+8K241912BiochargeNanofiber Solutions, LLC20240—
+8K240835Suture Button Repair SystemSkeletal Dynamics, Inc.20241—
+8K240194ProCinch, QuadCinchRiverpoint Medical20240—
+8K233552IDEAL ZiploopRiverpoint Medical20230—
+8K231641Rotium Bioresorbable WickNanofiber Solutions, LLC20231—
+8K230212OrthoButton ALRiverpoint Medical, LLC20232—
+8K202399OrthoButton FLRiverpoint Medical20201—
+8K201414Rotium Bioresorbable WickNanofiber Solutions, LLC20202—
+9K261770Suture Button Repair SystemSkeletal Dynamics, Inc.20260—