510(k) Report

Devices descending from K972326

488 later devices reach Peba Anchor/Suture Combination through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K201786Arthrex Mini Hip PushLockArthrex, Inc.20205—
+5K193108Bonecam Suture AnchorValeris Medical, Inc.20200—
+5K200341Arthrex FiberTak Suture AnchorArthrex, Inc.202017—
+5K192484Fixone Biocomposite AnchorAju Pharm Co., Ltd.20203—
+5K191709V-STRUT Vertebral ImplantHyprevention Sas20202—
+5K193461MectaLock All-Suture AnchorsMedacta International S.A.20203—
+5K191426FiberTak ButtonArthrex, Inc.20190—
+5K190288Arthrex Tenodesis ButtonArthrex, Inc.20194—
+5K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantMedos International SARL20191—
+5K190892MectaScrew PEEK Interference ScrewMedacta International S.A.20191—
+5K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+5K190333Paradigm All-Suture Anchor 1.8mm, White/Black #2Conmed Corporation20190—
+5K183501Parcus Twist AP Suture AnchorsParcus Medical, LLC20192—
+5K182736OIC Suture Anchor SystemThe Orthopaedic Implant Company20180—
+5K182446TruShot with Y-Knot All-Suture AnchorConmed Corporation20180—
+5K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+5K180573Responsive Arthroscopy Interference Screw SystemResponsive Arthroscopy, LLC20182—
+5K181262SpineJack Expansion KitVexim SA20184—
+5K173845Arthrex SwiveLockArthrex, Inc.20188—
+5K181809GRYPHON® Anchors with DYNACORD™ SutureMedos International SARL20180—
+5K181083Stryker All-PEEK Knotless Anchor SystemStryker201812
+5K173074ICONIX XBraid TT with Needles, NanoTack TT Suture AnchorStryker20185—
+5K173788Arthrex Corkscrew FTArthrex, Inc.20185—
+5K173278ToggleLoc SystemBiomet, Inc.20183—
+5K170868FIXIT Threaded Anchor SystemS.B.M Sas Science For Bio Materials20172—
+5K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC20170—
+5K172612FiberTak DXArthex, Inc.20170—
+5K170639HEALIX ADVANCE Anchor with PERMATAPE SutureMedos International SARL20171—
+5K171141Arthrex SwiveLock AnchorsArthrex, Inc.201729—
+5K170440KISSloc Suture SystemArthrosurface, Inc.20171—
+5K163440Stealth Staple SystemFirst Ray, LLC20173—
+5K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc.20160—
+5K153558Ventix Suture AnchorBiomet Manufacturing Corp20160—
+5K153211M-Fix Acromioclavicular DeviceCoracoid Solutions, Inc.20160—
+5K151004PULLUP® Adjustable Juxtacortical Fixation DeviceSbm Sciences For Bio Materials20152—
+5K151220Dunamis Interference ScrewDunamis, LLC20150—
+5K151314CinchLock Flex Knotless Suture AnchorPivot Medical201502
+5K151230Arthrex FiberTak AnchorsArthrex, Inc.201527—
+5K150359Tensyn PlugDallen Medical, Inc.20150—
+5K142948BIOSURE REGENESORB interference ScrewSmith & Nephew, Inc.201501
+5K141264Tensyn Band, Tensyn Fracture PlatesDallen Medical, Inc.20142—
+5K141141Kiva VCF Treatment SystemBenvenue Medical, Inc.20140—
+5K140879Biosure Healicoil PK Interference ScrewSmith & Nephew, Inc.20141—
+5K133036Apollo Suture Anchor System and Titan ScrewsAmendia, Inc.201471
+5K133671Iconix All Suture AnchorsStryker Corp.201425—
+5K132867Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor with…Cayenne Medical, Inc.20137—
+5K1325905.5MM Multifix S Knotless Fixation Device, 6.5MM Multifix S Knotless Fixation Device…ArthroCare Corporation20133—
+5K131974Healix Advance Knotless BR Anchor (6.5MM)Depuy Mitek, A Johnson & Johnson Company20133—
+5K131035Y-Knot Flex All-Suture Anchor, W/ Two #2 (5 Metric) HI-FI Sutures, 1.8MMLinvatec Corporation D/B/A Conmed Linvatec201317—
+5K123240Speedlock Hip Knotless Fixation ImplantArthroCare Corporation20130—
+5K122596Arthroscopic Surgical Instruments - Interference Screw SystemsSmith & Nephew, Inc.20120—
+5K122314Quatro Link Knotless Anchor with Inserter, 2.9MM-Peek OnlyCayenne Medical, Inc.20126—
+5K121890Genesys Pressft Suture AnchorLinvatec Corporation D/B/A Conmed Linvatec20120—
+5K120078Healix Advance BR AnchorDepuy Mitek Inc., Johnson and Johnson Company20129—
+5K113591Cols PeekFournitures Hospitalieres Industrie20110—
+5K113299Rog Suture AnchorRog Sports Medicine, Inc.20112—
+5K112991Modified Rog Suture AnchorRog Sports Medicine, Inc.20111—
+5K1107815.5 / 6.5MM Spartan Peek Surture Implant with #2 Magnumwire / with Needles, Extraction…Arthrocare Corp.20110—
+5K110660Arthrex Biocomposite SuturetakArthrex, Inc.201164—
+5K1101645.5MM Spartan Peek Suture Implant W/ #2 Magnum Wire, Punch Tap, Extraction ToolArthrocare Corp.20111—
+5K100012Gryphon T BR DS Anchor W/Orthocord, Gryphon T BR Anchor W /Orthocord, Gryphon P BR DS…Depuy Mitek, A Johnson & Johnson Company201024—
+5K093943Biosure Sync Tibial Fixation Device, 6MM, 8MM,10MM,12MMSmith & Nephew Inc., Endoscopy Div.20101—
+5K093228Smith & Nephew Twinfix Ultra PK Suture AnchorSmith & Nephew, Inc.200919—
+5K091094Parcus V-Lox Peek CF Suture Anchor, Models: 10253, 10254, 10263, 10264Parcus Medical, LLC20097—
+5K091093Parcus Ppek CF Interference ScrewParcus Medical, LLC20094—
+5K090124Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model 210813,210814Depuy Mitek, A Johnson & Johnson Company2009252
+6K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc.20260—
+6K261632Thunderbolt SystemResponsive Arthroscopy, Inc.20260—
+6K253027Anchor with Fiber Wire and Disposable InserterOrtobio S.A.20260—
+6K260317Artelon Convenience KitsInternational Life Sciences20260—
+6K260294SF Push-in AnchorSurgical Fusion Technologies GmbH20260—
+6K260561Arthrex FiberTak Suture AnchorArthrex, Inc.20260—
+6K254176SinefixBAAT Medical Products B.V.20260—
+6K253763Y-Knotless™ Flex AnchorsConmed Corporation20261—
+6K253618QuadLock™ Fixation SystemAbanza Tecnomed S.L20260—
+6K253040Aevumed FASE Suture AnchorAevumed, Inc.20253—
+6K251310OTS 25-L (100-5)Ots Medical, Ltd.20250—
+6K251933SnugFit ASA ExtensionMedacta International S.A.20250—
+6K250844PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip…Science & Bio Materials (S.B.M.) Sas20250—
+6K251309OSSIOfiber® Suture AnchorOSSIO, Ltd.20251—
+6K250526Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture AnchorArthrex, Inc.20250—
+6K242529Tigon Medical All-Suture Anchors (ASA)Tigon Medical20242—
+6K243467Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)Osteonic Co., Ltd.20240—
+6K243470Fix2Lock (PEEK Self Punching)Osteonic Co., Ltd.20240—
+6K242494OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel ConstructRiverpoint Medical, LLC20240—
+6K241932OSSIOfiber® Compression StapleOSSIO, Ltd.20240—
+6K240035TACTIX Vector Syndesmosis SystemVilex, LLC20241—
+6K240947TENSOR® Suture Button SystemGlobus Medical, Inc.20240—
+6K241235Arthrex TightRope IIArthrex, Inc.20243—
+6K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+6K240407ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture…Stryker Endoscopy20240—
+6K240084V-STRUT® Vertebral ImplantHyprevention20240—
+6K233302OSSIOfiber® Compression StapleOSSIO, Ltd.20231—
+6K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+6K232411JuggerKnot Soft Anchor OCRiverpoint Medical, LLC20232—
+6K231078All-Suture AnchorRiverpoint Medical, LLC20233—
+6K232513X-Twist Biocomposite Suture AnchorParcus Medical20230—
+6K230094Responsive Arthroscopy Stealth and Mini Stealth All-Suture AnchorsResponsive Arthroscopy, LLC20231—
+6K231787ecoFIX®Science & Bio Materials (S.B.M.) Sas20230—
+6K231326Fix2Lock (Biocomposite medial, lateral, Biocombi Self Punching)Osteonic Co., Ltd.20231—