FDA 510(k) Applications Submitted by ARTHREX, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K251809 06/12/2025 Arthrex FiberTak Suture Anchor Arthrex, Inc.
K020043 01/07/2002 4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B; 5.5 MM ARTHREX BIO-TENODESIS SCREW, MODELS AR-1555B ARTHREX, INC.
K050259 02/03/2005 ARTHREX BIO-PIN ARTHREX, INC.
K050358 02/14/2005 ARTHERX CORKSCREW FT II SUTURE ANCHOR ARTHREX, INC.
K060478 02/23/2006 ARTHREX BIO-COMPRESSION SCREW ARTHREX, INC.
K050749 03/23/2005 ARTHREX TAK FAMILY ARTHREX, INC.
K011007 04/04/2001 TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55 ARTHREX, INC.
K021434 05/06/2002 ARTHREX FIBERWIRE IN USP SIZES ARTHREX, INC.
K041189 05/06/2004 ARTHREX TRIMIT FAMILY ARTHREX, INC.
K011495 05/15/2001 ARTHREX BIO-POST AND WASHER ARTHREX, INC.
K041356 05/20/2004 ARTHREX TENODESIS SCREW FAMILY ARTHREX, INC.
K031666 05/29/2003 ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS ARTHREX, INC.
K041553 06/09/2004 ARTHREX SUTURE GRAFTING KIT ARTHREX, INC.
K041589 06/11/2004 ARTHREX FIBERWIRE WITH SILK ARTHREX, INC.
K061665 06/14/2006 ARTHREX 4.5 MM, 5.5 MM AND 6.5 MM CORKSCREW FT ARTHREX, INC.
K071622 06/14/2007 ARTHREX FIBERWIRE ARTHREX, INC.
K031945 06/24/2003 ARTHREX TRIMIT SCREW, MODEL AR-4161B ARTHREX, INC.
K061863 06/30/2006 ARTHREX CORKSCREW SUTURE ANCHOR, TAK, AND PUSHLOCK FAMILY ARTHREX, INC.
K032098 07/08/2003 ARTHREX BIO-COMPRESSION SCREW, SMALL, ARTHREX BIO-COMPRESSION SCREW, LARGE, MODELS AR-5024B, AR-5025B ARTHREX, INC.
K022234 07/11/2002 ARTHREX WRIST BIO-ANCHOR, MODEL AR-1322B ARTHREX, INC.
K032245 07/22/2003 ARTHREX FIBERTAPE (TM), 2MM, ARTHREX FIBERTAPE (TM), 3MM, ARTHREX FIBERTAPE (TM), 4MM, MODELS AR-7237, AR-7238, AR-7239 ARTHREX, INC.
K062466 08/24/2006 ARTHREX INTERFERENCE SCREW ARTHREX, INC.
K072378 08/24/2007 PROWICK ANTIMICROBIAL POSTOPERATIVE WOUND DRESSING, SHOULDER AND KNEE, MODELS AR-1625, AR-1626 ARTHREX, INC.
K012923 08/31/2001 ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201 ARTHREX, INC.
K052387 08/31/2005 ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX ARTHREX, INC.
K062747 09/14/2006 ARTHREX RETROBUTTON, 15MM, 60MM, RETROBUTTON, LONG, 15MM, 60MM ARTHREX, INC.
K023119 09/19/2002 BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B ARTHREX, INC.
K052607 09/22/2005 ARTHREX INTERFERENCE SCREW-ROUNDED HEAD SCREWS, FULL THREADED SCREWS, SHEATHED CANNULATED INTERFERENCE SCREWS ARTHREX, INC.
K052736 09/30/2005 ARTHREX K-WIRE ,THREADED MODELS AR-8990 TO 899X, AR-8991T TO AR-899XT ARTHREX, INC.
K052901 10/14/2005 ARTHREX TENSIONLOK ARTHREX, INC.
K063479 11/17/2006 ARTHREX PUSHLOCK ARTHREX, INC.
K053338 12/01/2005 ARTHREX TITANIUM AND BIO-DEGRADABLE (POLYMER) IMPLANTS ARTHREX, INC.
K023986 12/02/2002 ARTHREX OPES ELECTRODES AND ACCESSORIES ARTHREX, INC.
K063719 12/15/2006 ARTHREX CROSSPIN, MODEL AR-1964P ARTHREX, INC.
K014155 12/19/2001 OPENING/CLOSING WEDGE OSTETOMY PLATES ARTHREX, INC.
K053543 12/20/2005 ARTHREX ARTHOERESIS IMPLANT ARTHREX, INC.
K050634 03/09/2005 MODIFICATION TO: ARTHREX V-TAK ARTHREX, INC.
K071176 04/27/2007 MODIFICATION TO: ARTHREX INTERFERENCE SCREW ARTHREX, INC.
K010673 03/06/2001 ARTHREX FIBERWIRE, MODEL SPU-02NB-3800 ARTHREX, INC.
K190953 04/11/2019 Arthrex Minimally Invasive Ankle Fusion Plate Arthrex, Inc.
K120155 01/18/2012 ARTHREX KNOTLESS SUTURETAK ANCHOR ARTHREX, INC.
K130458 02/22/2013 KNOTLESS FIBERTAK SUTURE ANCHOR ARTHREX, INC.
K121124 04/13/2012 ARTHREX MIXING AND DELIVERY SYSTEM ARTHREX, INC.
K112990 10/06/2011 ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE ARTHREX, INC.
K123341 10/31/2012 ARTHREX PEC REPAIR BUTTON, ARTHREX LARGE PEC BUTTON, ARTHREX BICEPS BUTTON, ARTHREX PROXIMAL BICEPS BUTTON ARTHREX, INC.
K140019 01/03/2014 ARTHREX BIOSUTURE ARTHREX, INC.
K120044 01/05/2012 ARTHREX UNIVERSII XL GLENOID-PEGGED, ARTHREX UNIVERS II XL GLENOID-KEELED ARTHREX, INC.
K130129 01/17/2013 UNIVERS REVERS SHOULDER PROSTHESIS SYSTEM ARTHREX, INC.
K110123 01/18/2011 PCL TIGHTROPE ARTHREX, INC.
K160461 02/19/2016 Arthrex iBalance BiCompartmental Arthroplasty System Arthrex, Inc.
K120540 02/23/2012 BIOBOLT ARTHREX, INC.
K140476 02/26/2014 ARTHREX FIBERTAK SUTURE ANCHOR ARTHREX, INC.
K110660 03/07/2011 ARTHREX BIOCOMPOSITE SUTURETAK ARTHREX, INC.
K130675 03/13/2013 ARTHREX UNIVERS II CA HEADS ARTHREX, INC.
K161108 04/20/2016 Arthrex VaultLock Glenoid ARTHREX, INC.
K111253 05/04/2011 ARTHREX DISTAL EXTREMITY PLATE SYSTEM ARTHREX, INC.
K131474 05/22/2013 ARTHREX DISTAL RADIUS PLATE SYSTEM ARTHREX, INC.
K131633 06/04/2013 ARTHREX UNIVERS APEX ARTHREX, INC.
K151527 06/08/2015 Arthrex Univers Revers CA Heads and Adapters ARTHREX, INC.
K111661 06/14/2011 ARTHREX SCAPHOLUNATE ANCHOR ARTHREX, INC.
K101679 06/15/2010 ARTHREX PUSHLOCK ANCHORS ARTHREX, INC.
K151732 06/26/2015 Arthrex Fracture Plates ARTHREX, INC.
K132217 07/17/2013 ARTHREX COMPRESSION FT SCREWS ARTHREX, INC.
K112237 08/04/2011 MICROSUTURE ANCHORS ARTHREX, INC.
K172371 08/07/2017 Arthrex UNIVERS REVERS COATED BASEPLATE Arthrex, Inc.
K112437 08/24/2011 ARTHREX FRACTURE SYSTEM ARTHREX, INC.
K142863 10/01/2014 Univers Rivers Shoulder Prosthesis System Arthrex, Inc.
K123241 10/17/2012 ARTHREX FRACTURE PLATES ARTHREX, INC.
K103060 10/18/2010 ARTHREX TIBIAL GRAFTBOLT ARTHREX, INC.
K153115 10/28/2015 Arthrex Univers Apex, Size 5 Stem ARTHREX, INC.
K103705 12/20/2010 LOW PROFILE SCREWS ARTHREX, INC.
K093912 12/22/2009 ARTHREX TIBIAL GRAFTBOLT ARTHREX, INC.
K143139 11/03/2014 Arthrex Fracture System ARTHREX, INC.
K143702 12/24/2014 Arthrex Blunt Tip Screws with Fiber Tape Arthrex, Inc.
K150456 02/20/2015 Arthrex Plates, Screws, and Staples Arthrex, Inc.
K140855 04/03/2014 ARTHREX SUTURETAK SUTURE ANCHORS ARTHREX, INC.
K161060 04/15/2016 Arthrex iBalance UKA System Vitamin E Tibial Bearing Arthrex, Inc.
K151078 04/22/2015 Arthrex RetroFusion Screw ARTHREX, INC.
K151092 04/23/2015 Arthrex Short Suture Anchors Arthrex, Inc.
K141478 06/04/2014 ARTHREX FRACTURE PLATES AND SCREWS ARTHREX, INC.
K201542 06/09/2020 Arthrex Eclipse Shoulder Prosthesis System Arthrex, Inc.
K141577 06/13/2014 ARTHREX PIP DART ARTHREX, INC.
K161782 06/29/2016 Arthrex Univers Revers Shoulder Prosthesis System ARTHREX, INC.
K153218 11/05/2015 Arthrex Synergy UHD4 System ARTHREX, INC.
K143614 12/19/2014 Arthrex Low Profile Screws ARTHREX, INC.
K143745 12/31/2014 Arthrex Corkscrew and SwiveLock Suture Anchors Arthrex, Inc.
K151342 05/19/2015 Arthrex SwiveLock Anchors ARTHREX, INC.
K181769 07/03/2018 Arthrex FiberTak Suture Anchor Arthrex, Inc.
K233971 12/15/2023 Arthrex AlloSync PushLock Suture Anchor Arthrex, Inc.
K100652 03/08/2010 ACL TIGHTROPE ARTHREX, INC.
K101837 07/01/2010 ACL TIGHTROPE DOUBLE BUNDLE ARTHREX, INC.
K201134 04/28/2020 Arthrex NanoScope System Arthrex, Inc.
K170326 02/02/2017 dynaMX Intramedullary Implant Arthrex, Inc.
K170206 01/24/2017 Arthrex FiberTape Cerclage ARTHREX, INC.
K160319 02/05/2016 FiberTak DR ARTHREX, INC.
K170547 02/24/2017 Arthrex Mesh Plate System Arthrex, Inc.
K130510 02/27/2013 ARTHREX COMPRESSION PLATES ARTHREX, INC.
K180594 03/06/2018 Knotless SutureTak Anchors Arthrex, Inc.
K171296 05/02/2017 SutureTape Arthrex, Inc.
K151230 05/08/2015 Arthrex FiberTak Anchors Arthrex, Inc.
K091844 06/22/2009 ARTHREX BIO-COMPOSITE SUTURETAK ANCHORS ARTHREX, INC.
K122374 08/06/2012 ARTHREX SUTURE (UHMWPE) ARTHREX, INC.
K971358 04/11/1997 BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MM ARTHREX, INC.
K945303 10/28/1994 ARTHREX BIOABSORBABLE INTERFERENCE SCREW ARTHREX, INC.
K241592 06/03/2024 Arthrex VAL and VAL KreuLockÖ Compression Screw System Arthrex, Inc.
K242554 08/27/2024 Arthrex VAL and VAL KreuLockÖ Compression Screw System Arthrex, Inc.
K243195 10/01/2024 Arthrex SS VAL and VAL KreuLockÖ Compression Screw System Arthrex, Inc.
K250920 03/27/2025 Arthrex Spine Compression FT Screw Arthrex, Inc.
K241235 05/02/2024 Arthrex TightRope II Arthrex, Inc.
K250728 03/11/2025 Arthrex Synergy Vision Endoscopic Imaging System Arthrex, Inc.
K241361 05/14/2024 Arthrex Synergy Vision Endoscopic Imaging System Arthrex, Inc.
K212146 07/09/2021 Arthrex LoopLoc Knotless Suture Arthrex, Inc.
K243008 09/26/2024 Arthrex NanoScope System Arthrex, Inc.
K233451 10/20/2023 Arthrex Synergy Vision Endoscopic Imaging System Arthrex, Inc.
K243602 11/21/2024 Arthrex Spine Endoscope Arthrex, Inc.
K150648 03/12/2015 Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm ARTHREX, INC.
K141735 06/27/2014 ARTHREX ANKLE FUSION PLATING SYSTEM ARTHREX, INC.
K143047 10/23/2014 Arthrex iBalance Patella Implant, Dome ARTHREX, INC.
K143749 12/31/2014 Arthrex Distal Radius System Arthrex, Inc.
K152252 08/10/2015 Arthrex iBalance TKA System ARTHREX, INC.
K152382 08/24/2015 Arthrex iBalance TKA System ARTHREX, INC.
K153586 12/16/2015 Arthrex iBalance TKA System Arthrex, Inc.
K141635 06/19/2014 ARTHREX IBALANCE TKA SYSTEM ARTHREX, INC.
K132043 07/02/2013 ARTHREX SPEEDCINCH ARTHREX, INC.
K133854 12/19/2013 ARTHREX IBALANCE TKA SYSTEM ARTHREX, INC.
K071177 04/27/2007 ARTHREX BIO- COMPOSITE SUTURE ANCHORS: BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK, BIO-COMPOSITE CORKSCREW ARTHREX, INC.
K071456 05/25/2007 ARTHREX PROSTOP PLUS ARTHROEREISIS SUBTALAR IMPLANT ARTHREX, INC.
K133342 10/30/2013 ARTHREX IBALANCE TKA SYSTEM ARTHREX, INC.
K140328 02/10/2014 CMC MINI TIGHTROPE ARTHREX, INC.
K071032 04/11/2007 ARTHREX UNIVERS II SHOULDER PROSTHESIS ARTHREX, INC.
K062679 09/08/2006 ARTHREX CORKSCREW FT III SUTURE ANCHOR WITH THREE #2 SUTURES ARTHREX, INC.
K082810 09/24/2008 ARTHREX BIO-COMPOSITE SUTURE ANCHORS: ARTHREX BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK AND BIO-COMPOSITE CORKSCREW ARTHREX, INC.
K063058 10/05/2006 ARTHREX ANATOEMIC PHALANGEAL PROSTHESIS ARTHREX, INC.
K082999 10/08/2008 ARTHREX MENISCAL DART, ARTHREX MENISCAL DARTSTICK, ARTHREX CHONDRAL DART ARTHREX, INC.
K133275 10/24/2013 MINI TIGHTROPE ARTHREX, INC.
K051726 06/28/2005 ARTHREX TENODESIS FAMILY ARTHREX, INC.
K173656 11/29/2017 Arthrex FibuLock Nail Arthrex, Inc.
K250526 02/24/2025 Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor Arthrex, Inc.
K030096 01/10/2003 VIDEO ARTHROSCOPE, MODELS AR-3050-30, AR-3050T-30, AR-3050-70, AR-3051-30, AR-3052-30, AR3030AN, AR-3030AS, AR3030AW ARTHREX, INC.
K090107 01/15/2009 MINI TIGHTROPE ARTHREX, INC.
K080111 01/16/2008 ARTHREX COMPRESSION STAPLE ARTHREX, INC.
K040381 02/17/2004 HATRIC, 6&7MM, 9&10MM, 11&12MM, 14&15MM, MODELS AR-13000B-07, -10, -12, -15 ARTHREX, INC.
K040907 04/07/2004 ARTHREX SMALL FRAGMENT PLATES AND SCREWS ARTHREX, INC.
K091018 04/09/2009 ARTHREX BIOWIRE ARTHREX, INC.
K051219 05/12/2005 PUSHLOCK ARTHREX, INC.
K101823 06/30/2010 ARTHREX SWIVELOCK ANCHORS ARTHREX, INC.
K061925 07/07/2006 MINI TIGHTROPE REPAIR KIT, MODEL AR-8911DS ARTHREX, INC.
K032187 07/17/2003 ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM ARTHREX, INC.
K071978 07/18/2007 MINI TIGHTROPE FT REPAIR KIT ARTHREX, INC.
K112040 07/18/2011 ARTHREX BIOCOMPOSITE TRANSFIX ARTHREX, INC.
K041965 07/21/2004 ARTHREX HUMERAL FRACTURE PLATES AND SCREWS ARTHREX, INC.
K062365 08/14/2006 ARTHREX ASPIRATE KIT ARTHREX, INC.
K052614 09/23/2005 LOW PROFILE PLATE AND SCREW SYSTEM ARTHREX, INC.
K052776 10/03/2005 TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE, TITANIUM, STAINLESS STEEL , MODELS AR-2257, AR-TBD ARTHREX, INC.
K112899 10/03/2011 ARTHREX BIO-SUTURE ARTHREX, INC.
K083007 10/08/2008 PROWICK ARTHREX, INC.
K073149 11/08/2007 MENISCAL CINCH ARTHREX, INC.
K043145 11/15/2004 BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B ARTHREX, INC.
K043248 11/23/2004 TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS; STAINLESS STEEL. MODEL AR-8921DS ARTHREX, INC.
K043337 12/03/2004 ARTHREX BIO-CORKSCREW FT SUTURE ANCHOR ARTHREX, INC.
K083707 12/15/2008 ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE ARTHREX, INC.
K024291 12/24/2002 ARTHREX CONTINUOUS WAVE III ARTHOSCOPY PUMP, MODEL AR-6475 ARTHREX, INC.
K103466 11/24/2010 ARTHREX UNIVERS II SHOULDER PROSTHESIS ARTHREX, INC.
K083435 11/20/2008 ARTHREX UNIVERS II SHOULDER PEGGED GLENOID ARTHREX, INC.
K960516 02/05/1996 FASTAK SUTURE ANCHOR ARTHREX, INC.
K981187 04/02/1998 ACL AVULSION LAG SCREW WITH SHEATH MODEL NUMBER AR-6001 ARTHREX, INC.
K971723 05/09/1997 FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM) ARTHREX, INC.
K973812 10/07/1997 ARTHREX PUDDU OSTEOTOMY SYSTEM ARTHREX, INC.
K983577 10/13/1998 ARTHREX MENISCAL DART SYSTEM ARTHREX, INC.
K983843 10/30/1998 BIO-BUTTON 6.5MM, BIO-BUTTON 8MM, MODEL #'S AR-2236B & AR-2238B ARTHREX, INC.
K974847 12/29/1997 5.0MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22255, 3.5MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22235 ARTHREX, INC.
K230257 01/31/2023 Arthrex Intramedullary Nails Arthrex, Inc.
K230435 02/17/2023 Arthrex 3.9 mm SwiveLock Anchor Arthrex, Inc.
K241097 04/22/2024 Arthrex Virtual Implant Positioning (VIP) System Software Arthrex, Inc.
K010124 01/16/2001 ARTHREX UNIVERS 30 SHOULDER PROSTHESIS ARTHREX, INC.
K020345 02/01/2002 ARTHREX UNIVERS FRACTURE PROSTHESIS ARTHREX, INC.
K000506 02/15/2000 BIO-FASTAK SUTURE ANCHOR, MODEL AR-1324B ARTHREX, INC.
K010457 02/16/2001 ARTHREX TWISTLOC SUTURE ANCHOR, MODEL AR-1924 ARTHREX, INC.
K010525 02/22/2001 ARTHREX TENODESIS SCREW 7MM, 8MM, 9MM ARTHREX, INC.
K990987 03/24/1999 BIO-ABSORBABLE CORKSCREW, MODEL AR-1920B ARTHREX, INC.
K011172 04/17/2001 ARTHREX BIO-TRANSFIX ARTHREX, INC.
K003227 10/16/2000 BIO-ABSORBABLE CORKSCREW MODEL AR-1920B ARTHREX, INC.
K990340 02/03/1999 ARTHREX PLA TISSUETAK, MODEL # AR-1940 BU ARTHREX, INC.
K990361 02/05/1999 HEADED BIO-ABSORBABLE CORKSCREW MODEL #AR-1921BU ARTHREX, INC.
K991971 06/11/1999 ARTHREX CHONDRAL DART, MODEL AR-4005B-18 ARTHREX, INC.
K003816 12/11/2000 ARTHREX TITANIUM CORKSCREW, 3.5 MM, ARTHREX TITANIUM CORKSCREW, 5.0 MM, ARTHREX TITANIUM CORKSCREW 6.5MM ARTHREX, INC.
K161581 06/08/2016 Arthrex Synergy RF System ARTHREX, INC.


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