Data / Medical devices / United States / Arthrex Manufacturing Inc.
Arthrex Manufacturing Inc.: FDA-registered device maker in Pendleton, SC, United States, 62 510(k) clearances
Arthrex Manufacturing Inc. is registered with the FDA (registration 3015231789) in Pendleton, SC, United States. It lists 84 device types. The FDA files 62 510(k) clearances under its listings, the newest dated January 15, 2020. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3015231789
- Address
- 130 Arthrex Drive, Pendleton, SC, United States, 29670
- Owner or operator
- ARTHREX, INC. (1220287)
- Roles
- Contract manufacturer, Contract sterilizer, Manufacturer
- First device listed
- January 27, 1994
- Registered through
- 2027
- Brand names listed
- ACCIN Patellofemoral System, ACCIN Total Knee System, ACCIN Uni-Knee System, ACL TightRope, AESCULAP STERILCONTAINER SYSTEM, AOS HUMERAL NAI, ARTHROERESIS IMPLANT, Apparatus, Traction, Non-Powered 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 15, 2020 | K193503 | Arthrex SwiveLock 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 |
| July 5, 2019 | K190645 | Arthrex NanoScope System | GCJ | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 26, 2019 | K183628 | Arthrex TensionLoc System | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 18, 2018 | K182361 | Arthrex Compression FT Screws | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 14, 2018 | K180768 | Arthrex SwiveLock Anchors | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 30, 2018 | K181513 | Arthrex PushLock Tenodesis Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 6, 2018 | K173845 | Arthrex SwiveLock | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 29, 2018 | K171841 | Arthrex Shoulder System | KWS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 22, 2018 | K172371 | Arthrex UNIVERS REVERS COATED BASEPLATE | PHX | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 1, 2018 | K173788 | Arthrex Corkscrew FT | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| February 12, 2018 | K180118 | Arthrex NanoSuture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 14, 2017 | K170414 | Arthrex Univers Revers Apex Humeral Stems | PHX | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 16, 2017 | K171020 | Arthrex Knotless SutureTak Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 11, 2017 | K170382 | Arthrex Compression Screws | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| February 24, 2017 | K161371 | Sonoma Fifth Metatarsal Repair System | HSB | Substantially Equivalent | Sonoma Orthopedic Products, 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 |
| December 15, 2016 | K161060 | Arthrex iBalance UKA System Vitamin E Tibial Bearing | HSX | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 10, 2016 | K160319 | FiberTak DR | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 15, 2016 | K153612 | ArthrexVIP Web Portal | LLZ | Substantially Equivalent | Custom Orthopaedic Solutions, Inc. | accessdata.fda.gov |
| February 19, 2016 | K153586 | Arthrex iBalance TKA System | MBH | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 23, 2015 | K153115 | Arthrex Univers Apex, Size 5 Stem | KWS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 16, 2015 | K152252 | Arthrex iBalance TKA System | MBH | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 5, 2015 | K151500 | Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS) | KWS | Substantially Equivalent | Custom Orthopaedic Solutions | accessdata.fda.gov |
| October 2, 2015 | K151501 | OrthoVis Web Portal | LLZ | Substantially Equivalent | Custom Orthopaedic Solutions, Inc. | accessdata.fda.gov |
| June 12, 2015 | K150376 | Sonoma Cancellous Bone Screw and Washer | HWC | Substantially Equivalent | Sonoma Orthopedics Products, Inc. | accessdata.fda.gov |
| April 9, 2015 | K143702 | Arthrex Blunt Tip Screws with Fiber Tape | HTY | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 3, 2015 | K143749 | Arthrex Distal Radius System | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 19, 2014 | K143047 | Arthrex iBalance Patella Implant, Dome | JWH | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 13, 2014 | K140476 | ARTHREX FIBERTAK SUTURE ANCHOR | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| February 27, 2014 | K133854 | ARTHREX IBALANCE TKA SYSTEM | JWH | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 30, 2014 | K140019 | ARTHREX BIOSUTURE | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 17, 2013 | K133342 | ARTHREX IBALANCE TKA SYSTEM | JWH | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 30, 2013 | K130675 | ARTHREX UNIVERS II CA HEADS | HSD | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 25, 2013 | K130510 | ARTHREX COMPRESSION PLATES | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 3, 2013 | K130458 | KNOTLESS FIBERTAK SUTURE ANCHOR | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| February 17, 2012 | K120155 | ARTHREX KNOTLESS SUTURETAK ANCHOR | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 19, 2011 | K111550 | SONOMA FASTRAC CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA FASTRAC XXYYY(X=DIA, YYY=LENGTH- IN MM) | HSB | Substantially Equivalent | Sonoma Orthopedic Products, Inc. | accessdata.fda.gov |
| March 31, 2011 | K110660 | ARTHREX BIOCOMPOSITE SUTURETAK | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 10, 2011 | K103036 | ALLOFUSE PLUS | MQV | Substantially Equivalent | Allosource, Inc. | accessdata.fda.gov |
| September 28, 2010 | K100112 | SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=LENGTH-IN MM) | HSB | Substantially Equivalent | Sonoma Orthopedic Products, Inc. | accessdata.fda.gov |
| August 28, 2009 | K090304 | WAVEON WRX BONE FIXATION SYSTEM | HRS | Substantially Equivalent | Sonoma Orthopedic Products, Inc. | accessdata.fda.gov |
| August 6, 2009 | K090107 | MINI TIGHTROPE | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 17, 2008 | K081127 | ACCIN TOTAL KNEE SYSTEM | JWH | Substantially Equivalent | Accelerated Innovation, LLC | accessdata.fda.gov |
| February 29, 2008 | K073120 | ACCIN PATELLOFEMORAL SYSTEM | KRR | Substantially Equivalent | Accelerated Innovation, LLC | accessdata.fda.gov |
| February 11, 2008 | K073149 | MENISCAL CINCH | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 17, 2008 | K071456 | ARTHREX PROSTOP PLUS ARTHROEREISIS SUBTALAR IMPLANT | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 29, 2007 | K071177 | ARTHREX BIO- COMPOSITE SUTURE ANCHORS: BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK, BIO-COMPOSITE CORKSCREW | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 26, 2007 | K061499 | OSFERION | MQV | Substantially Equivalent | Olympus America, Inc. | accessdata.fda.gov |
| January 19, 2007 | K063782 | ACCIN UNI-KNEE SYSTEM | HSX | Substantially Equivalent | Accin Corporation | accessdata.fda.gov |
| June 2, 2006 | K060670 | ACCIN UNI-KNEE SYSTEM | HSX | Substantially Equivalent | Accin Corporation | accessdata.fda.gov |
| January 26, 2006 | K053338 | ARTHREX TITANIUM AND BIO-DEGRADABLE (POLYMER) IMPLANTS | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 12, 2005 | K050749 | ARTHREX TAK FAMILY | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| February 18, 2005 | K043145 | BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 1, 2004 | K040907 | ARTHREX SMALL FRAGMENT PLATES AND SCREWS | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 14, 2004 | K032245 | ARTHREX FIBERTAPE (TM), 2MM, ARTHREX FIBERTAPE (TM), 3MM, ARTHREX FIBERTAPE (TM), 4MM, MODELS AR-7237, AR-7238, AR-7239 | GAT | Unknown | Arthrex, Inc. | accessdata.fda.gov |
| November 18, 2003 | K031666 | ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 7, 2002 | K021434 | ARTHREX FIBERWIRE IN USP SIZES | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 18, 2002 | K014155 | OPENING/CLOSING WEDGE OSTETOMY PLATES | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 1, 2000 | K000506 | BIO-FASTAK SUTURE ANCHOR, MODEL AR-1324B | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 10, 1998 | K973812 | ARTHREX PUDDU OSTEOTOMY SYSTEM | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 30, 1997 | K971723 | FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM) | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Balance, Analytical
- All makers of Screw, Fixation, Bone
- All makers of Fastener, Fixation, Nondegradable, Soft Tissue
- All makers of Washer, Bolt Nut
- All makers of Plate, Fixation, Bone
- All makers of Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Updated January 15, 2020. 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.