510(k) Report

Devices descending from K051726

137 later devices reach Arthrex Tenodesis Family through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252664GMReis Suture AnchorsGM Dos Reis Industria e Comercio Ltda.20251—
+1K200725Citregen Tendon Interference Screw and CitrelockAcuitive Technologies20204—
+1K183690Tenodesis Screw SystemParagon 28, Inc.20193—
+1K181513Arthrex PushLock Tenodesis AnchorArthrex, Inc.20181—
+1K151701Tenodesis screw systemNormed Medizin-Technik GmbH20160—
+1K141290Helical Ridge Peek Interference ScrewMedShape, Inc.20140—
+1K130716Bioretec Activascrew InterferenceBioretec, Ltd.20130—
+1K123350Eclipse Soft Tissue FastenerMedShape, Inc.20132—
+1K122869Milagro Interference ScrewsDepuy Mitek, A Johnson & Johnson Company20120—
+1K120589Milagro Interference ScrewsDepuy Mitek, A Johnson & Johnson Company20121—
+1K103831Depuy Mitek Milagro Interference Screw Model 231803, 231804, 231807, 231809Depuy Mitek, A Johnson & Johnson Company201118—
+1K110538Pro Fixation SystemSynovis Orthopedic & Woundcare20110—
+1K101823Arthrex Swivelock AnchorsArthrex, Inc.20111036
+2K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC20260—
+2K260018Arthrex FiberButtonArthrex, Inc.20260—
+2K253538TeKBrace Knotless AnchorTheramicro20260—
+2K254229Arthrex Nano FiberTak Suture AnchorArthrex, Inc.20260—
+2K254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.20260—
+2K241864Grappler Interference Screw SystemParagon 28, Inc.20241—
+2K240441MILAGRO Interference Screw; MILAGRO ADVANCE Interference ScrewDepuy Mitek20241—
+2K232592Citrelock® DuoAcuitive Technologies, Inc.20230—
+2K231002Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture…Suzhou Endophix Co., Ltd.20230—
+2K221468Citregen™ Tendon Interference Screw (TIS), Citrelock™ Tendon Fixation Device…Acuitive Technologies, Inc.20230—
+2K220833Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock…Acuitive Technologies, Inc.20221—
+2K210239CITRESPLINE and CITRELOCK ACL ImplantsAcuitive Technologies, Inc.20213—
+2K200428Multi-Drive Interference Screw SystemNvision Biomedical Technologies, Inc.20200—
+2K192532Arthrex SwiveLock AnchorArthrex, Inc.201916—
+2K173269KATOR Suture AnchorKator, LLC20182—
+2K151342Arthrex SwiveLock AnchorsArthrex, Inc.201638—
+2K150648Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture…Arthrex, Inc.20154—
+2K143745Arthrex Corkscrew and SwiveLock Suture AnchorsArthrex, Inc.201510—
+2K133579Multifilament Stainless Steel Sutures with CrimpsPontis Orthopaedics, LLC20140—
+2K132783Exoshape Duo Soft Tissue FastenerMedShape, Inc.20130—
+2K131635Rotation Medical Bone Staple (RMB Staple)Rotation Medical, Inc.20133—
+2K112249Healix Knotless (TM) AnchorDepuy Mitek, A Johnson & Johnson Company201113—
+2K110545Smith & Nephew Next Generation Fully Threaded Peek Suture Anchor (Ngftsa PK)Smith & Nephew, Inc.201140—
+3K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.20260—
+3K251750Trax EX AnchorTrax Surgical, Inc.20260—
+3K253693Strut Suture; No-Tie ButtonRiverpoint Medical, LLC20260—
+3K253895Arthrex SwiveLock Suture Anchor, 3.5 x 10 mmArthrex, Inc.20250—
+3K252022OSSIOfiber® Interference ScrewOSSIO, Ltd.20250—
+3K242477Shoulder Soft Tissue AnchorsSignature Orthopaedics Pty, Ltd.20250—
+3K231033CEPTRE® Knotted UHMWPE Suture PEEK AnchorHealthium Medtech Limited20240—
+3K223860Integrity™ Bone Staple Fixation SystemAnika Therapeutics, Inc.20231—
+3K230435Arthrex 3.9 mm SwiveLock AnchorArthrex, Inc.20231—
+3K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+3K213958Bioabsorbable AnchorEmbody, Inc.20220—
+3K202763Fix2Lock (PEEK Self Punching)Osteonic Co., Ltd.20212—
+3K201749Arthrex SwiveLock AnchorArthrex, Inc.202015—
+3K180951Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20194—
+3K182736OIC Suture Anchor SystemThe Orthopaedic Implant Company20180—
+3K180768Arthrex SwiveLock AnchorsArthrex, Inc.201828—
+3K173845Arthrex SwiveLockArthrex, Inc.20188—
+3K181083Stryker All-PEEK Knotless Anchor SystemStryker201812
+3K171141Arthrex SwiveLock AnchorsArthrex, Inc.201729—
+3K133671Iconix All Suture AnchorsStryker Corp.201425—
+3K130917Healix Advance Knotless BR AnchorDepuy Mitek, A Johnson & Johnson Company201392
+3K130539Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM)Depuy Mitek, A Johnson & Johnson Company20134—
+3K112526Twinfix Ultra TI, Twinfix Ultra PK, Twinfix Ultra HA Suture AnchorsSmith & Nephew, Inc.201213—
+3K113534Healix Knotless AnchorDepuy Mitek, A Johnson & Johnson Company20110—
+4K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc.20260—
+4K243726Osprey Suture AnchorResponsive Arthroscopy, Inc.20250—
+4K242529Tigon Medical All-Suture Anchors (ASA)Tigon Medical20242—
+4K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd.20240—
+4K240407ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture…Stryker Endoscopy20240—
+4K232973Arthrex Knee FiberTak® Button Suture AnchorArthrex, Inc.20234—
+4K230094Responsive Arthroscopy Stealth and Mini Stealth All-Suture AnchorsResponsive Arthroscopy, LLC20231—
+4K231322Fix2Lock (PEEK Self Punching)Osteonic Co., Ltd.20231—
+4K223284SutureLoc™ ImplantArthrex, Inc.20230—
+4K221396Arthrex FiberTak Suture AnchorArthrex, Inc.20223—
+4K222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsResponsive Arthroscopy, LLC20221—
+4K221364Mitek TIGHT-N AnchorMedos International SARL20220—
+4K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd.20211—
+4K203495Arthrex SwiveLock AnchorArthrex, Inc.2021131
+4K202355Stryker Omega PEEK Knotless Anchor SystemStryker20200—
+4K202153Responsive Arthroscopy Suture Anchor SystemResponsive Arthroscopy, LLC20201—
+4K193245Dunamis PunchTac Suture AnchorsDunamis, LLC20200—
+4K191227Paratrooper Plantar Plate Repair SystemParagon 28, Inc.20201—
+4K192441Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+4K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantMedos International SARL20191—
+4K191226Arthrex SwiveLock Suture AnchorArthrex, Inc.201921—
+4K190728Arthrex SwiveLock AnchorsArthrex, Inc.20192—
+4K183501Parcus Twist AP Suture AnchorsParcus Medical, LLC20192—
+4K180101HEALIX ADVANCE KNOTLESS BR AnchorMedos International SARL20181—
+4K171114HEALIX ADVANCE KNOTLESS AnchorMedos International SARL20172—
+4K171465Stryker Self-Punching ICONIXStryker20171—
+4K170098ICONIX TT All Suture AnchorStryker20173—
+4K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to…Smith & Nephew, Inc.201562
+4K151201Stryker ICONIX with NeedlesStryker201510—
+4K131974Healix Advance Knotless BR Anchor (6.5MM)Depuy Mitek, A Johnson & Johnson Company20133—
+4K131683Healix Advance Knotless Peek Anchor (6.5MM)Depuy Mitek, Inc., A Johnson and Johnson Company20133—
+5K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor LineTigon Medical20260—
+5K260561Arthrex FiberTak Suture AnchorArthrex, Inc.20260—
+5K260405FiberTape ButtonArthrex, Inc.20260—
+5K253695LigaMendRiverpoint Medical, LLC20260—
+5K252596Tigon Medical Knotless and Dual Javelin All-Suture AnchorsTigon Medical20251—
+5K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLC20250—
+5K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…Smith & Nephew, Inc.20250—
+5K251309OSSIOfiber® Suture AnchorOSSIO, Ltd.20251—
+5K250528Stryker AlphaVent™ Knotless SP Biocomposite AnchorStryker Endoscopy20250—