Data / Medical devices / China / Arthrex (Shanghai) Co., Ltd.
Arthrex (Shanghai) Co., Ltd.: FDA-registered device maker in Shanghai, China, 100 510(k) clearances
Arthrex (Shanghai) Co., Ltd. is registered with the FDA (registration 3014262693) in Shanghai, China. It lists 38 device types. The FDA files 100 510(k) clearances under its listings, the newest dated January 22, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3014262693
- Address
- 2205-2208 Garden Square 968 Beijing West Road, Shanghai, China, 200041
- Owner or operator
- ARTHREX, INC. (1220287)
- Roles
- Exporter to the US
- First device listed
- January 27, 1994
- Registered through
- 2027
- Brand names listed
- ACL TightRope, ACL TightRope Double Bundle, Apparatus, Traction, Non-Powered, Arthrex Ankle Fusion Plating System, Arthrex BioComposite SutureTak, Arthrex Biocomposite Transfix, Arthrex Distal Extremity Plate System, Arthrex Fracture Plates and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 22, 2025 | K243008 | Arthrex NanoScope System | GCJ | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 25, 2024 | K241361 | Arthrex Synergy Vision Endoscopic Imaging System | GCJ | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 29, 2024 | K241235 | Arthrex TightRope II | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 18, 2024 | K233451 | Arthrex Synergy Vision Endoscopic Imaging System | GCJ | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 15, 2023 | K232973 | Arthrex Knee FiberTak® Button Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 6, 2023 | K232755 | Arthrex FiberTape and TigerTape Cerclage Sutures | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 1, 2023 | K231330 | FiberTak® Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 18, 2023 | K231113 | Arthrex FiberTak Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 1, 2023 | K230568 | FiberTak Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 8, 2023 | K222007 | Arthrex Virtual Implant Positioning (VIP) System | QHE | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 22, 2022 | K221396 | Arthrex FiberTak Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 7, 2022 | K221731 | FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire | MBI | Substantially Equivalent | T.A.G. Medical Products Corporation, Ltd. | accessdata.fda.gov |
| August 22, 2022 | K221485 | Arthrex FiberTape and TigerTape Cerclage Sutures | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 11, 2022 | K222161 | Arthrex Knotless FiberTak Biceps Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 13, 2022 | K221099 | Arthrex Self-Punching PushLock Suture Anchor | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 19, 2021 | K203495 | Arthrex SwiveLock Anchor | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| February 3, 2021 | K203294 | Arthrex Pilon Fusion System | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 27, 2020 | K203268 | Arthrex FiberTak Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 18, 2020 | K202535 | Arthrex FastThread Interference Screw | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 4, 2020 | K202581 | Arthrex TightRope II | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 27, 2020 | K201132 | Arthrex Compression Screws | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 8, 2020 | K201542 | Arthrex Eclipse Shoulder Prosthesis System | PKC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 12, 2020 | K200341 | Arthrex FiberTak Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 12, 2019 | K193157 | Arthrex 3.9mm Corkscrew Suture Anchor | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 26, 2019 | K183194 | Arthrex Eclipse Shoulder Prosthesis System | QHQ | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 11, 2019 | K191226 | Arthrex SwiveLock Suture Anchor | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 21, 2018 | K181769 | Arthrex FiberTak Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 22, 2018 | K180594 | Knotless SutureTak Anchors | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 22, 2018 | K180662 | Arthrex FastThread Interference Screw | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 20, 2018 | K173900 | Arthrex Univers Revers Modular Glenoid System | PHX | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| February 12, 2018 | K180118 | Arthrex NanoSuture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 28, 2017 | K172612 | FiberTak DX | MBI | Substantially Equivalent | Arthex, Inc. | accessdata.fda.gov |
| September 1, 2017 | K170547 | Arthrex Mesh Plate System | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| February 10, 2017 | K162697 | Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal | KWS | Substantially Equivalent | Custom Orthopaedic Solutions, Inc. | accessdata.fda.gov |
| November 21, 2016 | K161782 | Arthrex Univers Revers Shoulder Prosthesis System | HSD | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 9, 2016 | K161581 | Arthrex Synergy RF System | GEI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 29, 2016 | K161108 | Arthrex VaultLock Glenoid | KWS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 19, 2016 | K151527 | Arthrex Univers Revers CA Heads and Adapters | HSD | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 24, 2016 | K151342 | Arthrex SwiveLock Anchors | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| February 23, 2016 | K151092 | Arthrex Short Suture Anchors | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| February 12, 2016 | K153218 | Arthrex Synergy UHD4 System | GCJ | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 2, 2015 | K143745 | Arthrex Corkscrew and SwiveLock Suture Anchors | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 19, 2015 | K151230 | Arthrex FiberTak Anchors | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 29, 2015 | K150456 | Arthrex Plates, Screws, and Staples | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 16, 2015 | K143614 | Arthrex Low Profile Screws | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 18, 2014 | K140855 | ARTHREX SUTURETAK SUTURE ANCHORS | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 25, 2014 | K142863 | Univers Rivers Shoulder Prosthesis System | PHX | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 15, 2014 | K141735 | ARTHREX ANKLE FUSION PLATING SYSTEM | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 8, 2014 | K141478 | ARTHREX FRACTURE PLATES AND SCREWS | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 30, 2014 | K133275 | MINI TIGHTROPE | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 25, 2013 | K132217 | ARTHREX COMPRESSION FT SCREWS | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 31, 2013 | K132043 | ARTHREX SPEEDCINCH | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 3, 2013 | K131474 | ARTHREX DISTAL RADIUS PLATE SYSTEM | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 3, 2013 | K130458 | KNOTLESS FIBERTAK SUTURE ANCHOR | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 5, 2013 | K123241 | ARTHREX FRACTURE PLATES | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 21, 2012 | K123341 | ARTHREX PEC REPAIR BUTTON, ARTHREX LARGE PEC BUTTON, ARTHREX BICEPS BUTTON, ARTHREX PROXIMAL BICEPS BUTTON | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 25, 2012 | K122374 | ARTHREX SUTURE (UHMWPE) | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 16, 2012 | K121124 | ARTHREX MIXING AND DELIVERY SYSTEM | FMF | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 19, 2011 | K112990 | ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE | HTY | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 15, 2011 | K112040 | ARTHREX BIOCOMPOSITE TRANSFIX | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 2, 2011 | K112237 | MICROSUTURE ANCHORS | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 2, 2011 | K111253 | ARTHREX DISTAL EXTREMITY PLATE SYSTEM | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 28, 2011 | K110123 | PCL TIGHTROPE | HTY | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 31, 2011 | K110660 | ARTHREX BIOCOMPOSITE SUTURETAK | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 18, 2011 | K103705 | LOW PROFILE SCREWS | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 7, 2011 | K101823 | ARTHREX SWIVELOCK ANCHORS | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 5, 2011 | K103060 | ARTHREX TIBIAL GRAFTBOLT | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 28, 2010 | K101837 | ACL TIGHTROPE DOUBLE BUNDLE | HTY | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 22, 2010 | K101679 | ARTHREX PUSHLOCK ANCHORS | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 23, 2010 | K100652 | ACL TIGHTROPE | HTY | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 18, 2010 | K093912 | ARTHREX TIBIAL GRAFTBOLT | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 28, 2009 | K091844 | ARTHREX BIO-COMPOSITE SUTURETAK ANCHORS | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 6, 2009 | K090107 | MINI TIGHTROPE | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 3, 2009 | K083707 | ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE | HRX | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 23, 2009 | K082810 | ARTHREX BIO-COMPOSITE SUTURE ANCHORS: ARTHREX BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK AND BIO-COMPOSITE CORKSCREW | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 18, 2008 | K080560 | HENKE SASS WOLF OF AMERICA ARTHROSCOPE | HRX | Substantially Equivalent | Henke Sass Wolf of America, Inc. | accessdata.fda.gov |
| February 13, 2008 | K080111 | ARTHREX COMPRESSION STAPLE | JDR | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| February 11, 2008 | K073149 | MENISCAL CINCH | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 20, 2007 | K071032 | ARTHREX UNIVERS II SHOULDER PROSTHESIS | KWS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 15, 2007 | K071756 | ENDOHUB- 1.0 ENDOSCOPIC VIDEO CAMERA SYSTEM WITH VIDEO CAPTURE | GCJ | Substantially Equivalent | Pointe Conception Medical, Inc. | accessdata.fda.gov |
| August 3, 2007 | K071176 | MODIFICATION TO: ARTHREX INTERFERENCE SCREW | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 13, 2006 | K063479 | ARTHREX PUSHLOCK | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 29, 2006 | K062466 | ARTHREX INTERFERENCE SCREW | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 19, 2006 | K061863 | ARTHREX CORKSCREW SUTURE ANCHOR, TAK, AND PUSHLOCK FAMILY | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 29, 2006 | K062747 | ARTHREX RETROBUTTON, 15MM, 60MM, RETROBUTTON, LONG, 15MM, 60MM | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 20, 2006 | K053510 | IR WIRELESS FOOT SWITCH | GEI | Substantially Equivalent | Linemaster Switch Corp. | accessdata.fda.gov |
| January 26, 2006 | K053338 | ARTHREX TITANIUM AND BIO-DEGRADABLE (POLYMER) IMPLANTS | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 13, 2005 | K052776 | TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE, TITANIUM, STAINLESS STEEL , MODELS AR-2257, AR-TBD | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 3, 2005 | K052736 | ARTHREX K-WIRE ,THREADED MODELS AR-8990 TO 899X, AR-8991T TO AR-899XT | HTY | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 28, 2005 | K052614 | LOW PROFILE PLATE AND SCREW SYSTEM | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 27, 2005 | K051726 | ARTHREX TENODESIS FAMILY | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 12, 2005 | K050749 | ARTHREX TAK FAMILY | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| February 16, 2005 | K043248 | TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS; STAINLESS STEEL. MODEL AR-8921DS | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 10, 2004 | K041553 | ARTHREX SUTURE GRAFTING KIT | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 22, 2003 | K032187 | ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 20, 2003 | K024291 | ARTHREX CONTINUOUS WAVE III ARTHOSCOPY PUMP, MODEL AR-6475 | HRX | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 7, 2002 | K021434 | ARTHREX FIBERWIRE IN USP SIZES | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| February 1, 1995 | K943492 | ARTHREX STAPLES | JDR | Substantially Equivalent for Some Indications | Arthrex, Inc. | accessdata.fda.gov |
| May 16, 1994 | K941541 | HSV LAPAROSCOPY SET | GCJ | Substantially Equivalent | Henke Sass Wolf of America, Inc. | accessdata.fda.gov |
| January 25, 1994 | K932699 | ARTHREX AR-8200 SHAVER SYSTEM | HWE | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
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Updated January 22, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.