Data / Medical devices / Germany / Arthrex GmbH
Arthrex GmbH: FDA-registered device maker in Munich Bavaria, Germany, 136 510(k) clearances
Arthrex GmbH is registered with the FDA (registration 3002579136) in Munich Bavaria, Germany. It lists 65 device types. The FDA files 136 510(k) clearances under its listings, the newest dated July 25, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3002579136
- Address
- Erwin-Hielscher-Strasse 9, Munich Bavaria, Germany, 81249
- Owner or operator
- ARTHREX, INC. (1220287)
- Roles
- Exporter to the US, Specification developer
- First device listed
- January 27, 1994
- Registered through
- 2027
- Brand names listed
- AESCULAP STERILCONTAINER SYSTEM, ANATOEMIC PROSTHESIS, ARTHREX ANATOEMIC P, ARTHROSCOPY LEG HOLDER, ARTHROSCOPY PUMP, Apparatus, Traction, Non-Powered, Arthrex Ankle Fusion Plating System, Arthrex BioComposite SutureTak 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. Newest 100 of 136.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| September 1, 2023 | K232340 | Arthrex 2.4mm Knotless Hip SutureTak® Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 8, 2023 | K231857 | Arthrex TightRope II | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 22, 2023 | K230904 | Arthrex Virtual Implant Positioning (VIP) System | QHE | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 18, 2023 | K231113 | Arthrex FiberTak Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| February 24, 2023 | K223759 | Arthrex SynergyID Endoscopic Imaging System | GCJ | Substantially Equivalent | Arthex, Inc. | accessdata.fda.gov |
| December 22, 2022 | K221396 | Arthrex FiberTak Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 3, 2022 | K222267 | Arthrex 2.4 mm Volar Distal Radius Plate System | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 30, 2022 | K222244 | Arthrex 3.5 mm Locking Compression Plates | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 19, 2022 | K220839 | Arthrex Compression FT Pins | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 14, 2022 | K222078 | Arthrex SoftStitch | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 9, 2022 | K221354 | Arthrex SutureTape | GAT | 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 26, 2022 | K222263 | Arthrex Self Punching SwiveLock Suture Anchors | MAI | Substantially Equivalent | Arthrex, Inc. | 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 |
| June 29, 2022 | K220937 | Arthrex Mini Fragment System | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 6, 2022 | K220947 | Arthrex Knotless AC Repair Devices | HTN | 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 |
| May 2, 2022 | K213837 | Arthrx Fracture Plates | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 17, 2021 | K213644 | Arthrex Knotless Mini TightRopes | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 7, 2021 | K210050 | Augmented VaultLock Glenoid | KWS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 1, 2021 | K210994 | Arthrex Beveled FT Screws | HWC | 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 17, 2020 | K202444 | Knotless TensionTight Button Implant System | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 4, 2020 | K202581 | Arthrex TightRope II | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 4, 2020 | K201134 | Arthrex NanoScope System | GCJ | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 3, 2020 | K201522 | Arthrex Syndesmosis TightRope XP Buttress Plate Implant System | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 27, 2020 | K201132 | Arthrex Compression Screws | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 24, 2020 | K193575 | Arthrex SutureTape | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 8, 2020 | K201542 | Arthrex Eclipse Shoulder Prosthesis System | PKC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 6, 2020 | K201235 | Arthrex MaxForce MTP Compression Plates and Screws | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 12, 2020 | K200341 | Arthrex FiberTak Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 15, 2020 | K193503 | Arthrex SwiveLock Suture Anchor | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 10, 2020 | K193372 | Univers Revers Modular Glenoid System (Augemented baseplates) | PHX | 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 |
| November 26, 2019 | K191426 | FiberTak Button | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 15, 2019 | K191326 | Arthrex Mini Comprehensive Fixation System 1.4mm & 1.6mm Module | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 3, 2019 | K191344 | Arthrex Mini Comprehensive Fixation System 2.0mm & 2.4mm Module | HRS | 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 |
| May 19, 2019 | K190125 | 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 |
| April 17, 2019 | K183395 | Arthrex 2.5 mm Tenodesis Screw | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 21, 2018 | K181555 | Arthrex Fracture Adapter Hemi Shoulder Prosthesis | KWS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 28, 2018 | K182039 | Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay | PHX | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 21, 2018 | K181769 | Arthrex FiberTak Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 6, 2018 | K173845 | Arthrex SwiveLock | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 22, 2018 | K180594 | Knotless SutureTak Anchors | 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 |
| March 1, 2018 | K173788 | Arthrex Corkscrew FT | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| February 23, 2018 | K171869 | Sutter CURIS RF Generator | GEI | Substantially Equivalent | Sutter Medizintechnik GmbH | accessdata.fda.gov |
| February 22, 2018 | K173381 | Nexxis OR | DXJ | Substantially Equivalent | Barco N.V. | accessdata.fda.gov |
| January 16, 2018 | K173240 | Arthrex PushLock | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 7, 2017 | K171365 | Arthrex Knee Systems | MBH | 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 |
| May 26, 2017 | K171296 | SutureTape | GAT | 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 12, 2016 | K160461 | Arthrex iBalance BiCompartmental Arthroplasty System | KRR | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 24, 2016 | K151342 | Arthrex SwiveLock Anchors | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 28, 2015 | K151732 | Arthrex Fracture Plates | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 20, 2015 | K150648 | Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm | 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 |
| April 9, 2015 | K143702 | Arthrex Blunt Tip Screws with Fiber Tape | HTY | 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 |
| September 27, 2013 | K131633 | ARTHREX UNIVERS APEX | KWS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 31, 2013 | K130129 | UNIVERS REVERS SHOULDER PROSTHESIS SYSTEM | KWS | 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 |
| 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 |
| March 8, 2012 | K120044 | ARTHREX UNIVERSII XL GLENOID-PEGGED, ARTHREX UNIVERS II XL GLENOID-KEELED | KWS | 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 |
| March 31, 2011 | K110660 | ARTHREX BIOCOMPOSITE SUTURETAK | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 7, 2011 | K101823 | ARTHREX SWIVELOCK ANCHORS | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 22, 2010 | K101679 | ARTHREX PUSHLOCK ANCHORS | MAI | 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 |
| June 26, 2009 | K083435 | ARTHREX UNIVERS II SHOULDER PEGGED GLENOID | KWS | 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 |
| December 30, 2008 | K082999 | ARTHREX MENISCAL DART, ARTHREX MENISCAL DARTSTICK, ARTHREX CHONDRAL DART | 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 11, 2008 | K073149 | MENISCAL CINCH | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
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Updated July 25, 2024. 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.