FDA 510(k) Applications Submitted by Arthrex, Inc.
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
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. |
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. |
K212146 |
07/09/2021 |
Arthrex LoopLoc Knotless Suture |
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. |
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. |
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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