Data / Medical devices / United States / ArthroCare Corporation
ArthroCare Corporation: FDA-registered device maker in Austin, TX, United States, 59 510(k) clearances
ArthroCare Corporation is registered with the FDA (registration 3006524618) in Austin, TX, United States. It lists 21 device types. The FDA files 59 510(k) clearances under its listings, the newest dated March 30, 2026. 17 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3006524618
- FEI number
- 3010813691
- Address
- 7000 W William Cannon Dr, Austin, TX, United States, 78735
- Owner or operator
- Smith & Nephew, Inc. (1020279)
- Roles
- Specification developer
- First device listed
- February 22, 1978
- Registered through
- 2027
- Brand names listed
- 1.2 RAP-PAC A LATEX FREE, 1.2 RAP-PAC A, 72202796, 1.2 RAP-PAC B LATEX FREE, 1.2 RAP-PAC B, 72202797, 1.2 RAP-PAC C, 1.5 MM TENDON DRILL PIN, 1.5mm Guidewire, 12", 72202189, 1.8MM Q-FIX ALL-SUTURE ANCHOR WITH ONE MINITAPE SUTURE (BLUE) 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 |
|---|---|---|---|---|---|---|
| March 30, 2026 | K254122 | FLOW FLEXTEND Wand (72290039) | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| March 25, 2026 | K253680 | LYNX COBLATION Laryngeal Wand (72290254) | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| May 8, 2024 | K240964 | FLOW 90? Wand | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| December 11, 2023 | K232290 | INTELLIO SHIFT System | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| June 26, 2023 | K230914 | ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146) | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| September 1, 2022 | K220563 | Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ COBLATION System | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| June 24, 2021 | K210423 | Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| December 18, 2020 | K202006 | ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation System | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| December 20, 2019 | K192027 | WEREWOLF COBLATION System, COBLATION HALO Wand | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| January 24, 2019 | K183346 | FLOW 90 Wand | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| May 1, 2018 | K180848 | AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| August 17, 2017 | K172165 | Q-Fix Suture Anchor | MBI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| January 6, 2017 | K163142 | SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader | GAT | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| October 21, 2016 | K161481 | Ambient HipVac 50 Wand with Integrated Finger Switches | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| September 29, 2016 | K162126 | Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KVac ICW) | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| August 22, 2016 | K162074 | Werewolf RF20000 Controller, FLOW 50 Wand | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| January 28, 2016 | K153186 | Adjustable Fixation Device | MBI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| January 19, 2016 | K153669 | MultiFIX S Ultra Knotless Fixation System | MBI | Substantially Equivalent | Arthocare Corporation | accessdata.fda.gov |
| January 15, 2016 | K153675 | Paragon T2 Wand with Integrated Cable | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| December 11, 2015 | K153313 | SpeedLock Knotless Fixation System | MBI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| October 23, 2015 | K143235 | RF20000a Controller, FLOW 50 Wand | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| August 6, 2015 | K151897 | MultiFIX® P Knotless Fixation Device | MBI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| March 5, 2015 | K143134 | NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV System | LOD | Substantially Equivalent | Cossington, Ltd. | accessdata.fda.gov |
| March 5, 2015 | K143100 | NP Cement HV Genta;NP Cement LV Genta;NP Cement HV System Genta;NP Cement LV System Genta | LOD | Substantially Equivalent | Cossington, Ltd. | accessdata.fda.gov |
| November 19, 2014 | K142999 | EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated Cable | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| June 16, 2014 | K140992 | ARTHROCARE NASASTENT CMC NASAL DRESSING | LYA | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| June 10, 2014 | K140521 | TOPAZ EZ MICRODEBRIDER COBLATION WAND WITH INTEGRATED FINGER SWITCH | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| January 16, 2014 | K133727 | Q-FIX SUTURE ANCHOR, 1.8MM; Q-FIX SUTURE ANCHOR, 2.8MM; DRILL, DRILL GUIDE AND OBTURATOR, 1.8MM & 2.8MM, FIRSTPASS SUTU | MBI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| August 9, 2013 | K131205 | ARTHROCARE HEAD AND NECK COBLATION WAND | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| July 2, 2013 | K122652 | ARTHROCARE TURBINATOR WAND | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| February 27, 2013 | K130196 | SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DR | MBI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| February 14, 2013 | K123240 | SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT | MBI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| November 7, 2012 | K123268 | SMARTSTITCH PERFECTPASSER SYSTEM | GAT | Substantially Equivalent | Arthocare Corporation | accessdata.fda.gov |
| October 29, 2010 | K101437 | SPEEDFIX SUTURE SYSTEM | MBI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| June 21, 2010 | K101448 | OPUS SPEEDSCREW SYSTEM | MBI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| April 22, 2010 | K093343 | GRAFTY QUICKSET | MQV | Substantially Equivalent | Graftys | accessdata.fda.gov |
| December 4, 2009 | K093165 | ARTHROCARE SYSTEM 15000 CONTROLLER, ARTHROWANDS | GEI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| June 23, 2009 | K090393 | ARTHROCARE SYSTEM 15000 CONTOLLER, MODEL 72202149, ARTHROCARE ARTHROWANDS, MODEL 72202139,72202141, 72202143, 72202144 | GEI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| January 6, 2009 | K082750 | ENTACT SEPTAL STAPLER, MODEL 610-00100 | OLL | Substantially Equivalent | Entrigue Surgical, Inc. | accessdata.fda.gov |
| December 10, 2008 | K083306 | MODIFICATION TO ARTHROCARE ARTHROWANDS | GEI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| October 15, 2008 | K082666 | ARTHROCARE CONTROLLER (SYSTEM 12000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD, WANDS | GEI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| October 1, 2008 | K081893 | OPUS MAGNUM SPEEDSCREW KNOTLESS FIXATION DEVICE, MODEL OM-6500 | HWC | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| July 28, 2008 | K081497 | OPUS MAGNUM2 KNOTLESS FIXATION DEVICE (MODEL OM-1502), OPUS MAGNUM X KNOTLESS FIXATION DEVICE (MODEL OM-1503) | MBI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| February 15, 2008 | K080282 | ARTHROCARE CONTROLLERS (SYSTEM 2000,1100,1200), MODEL H2076-00, H2079-00, H3000-00, H4000-00; | GEI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| April 25, 2007 | K070374 | ARTHROCARE ENT PLASMA WAND | GEI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| April 2, 2007 | K070673 | FORCE FIBER BLACK CO-BRAID POLYETHYLENE NON-ABSORBABLE SURGICAL SUTURE | GAT | Substantially Equivalent | Teleflexmedical, Inc. | accessdata.fda.gov |
| December 14, 2004 | K042584 | OPUS MINIMAGNUM ANCHOR WITH INSERTER | HWC | Substantially Equivalent | Opus Medical, Inc. | accessdata.fda.gov |
| November 12, 2004 | K042914 | OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE | MBI | Substantially Equivalent | Opus Medical, Inc. | accessdata.fda.gov |
| October 19, 2004 | K042031 | OPUS SPEEDSTITCH SUTURE DEVICE | GAT | Substantially Equivalent | Opus Medical, Inc. | accessdata.fda.gov |
| April 29, 2004 | K022688 | VERSABOND AB BONE CEMENT | LOD | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 28, 2003 | K033584 | ARTHROCARE ARTHROWANDS | GEI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| November 28, 2003 | K033509 | MODIFICATION TO VERSABOND BONE CEMENT | LOD | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 21, 2003 | K032504 | ARTHROCARE SYSTEM | GEI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| February 3, 2003 | K030108 | ARTHROCARE ENT COBLATOR SURGERY SYSTEM | GEI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| July 19, 2001 | K011279 | ENTEC EVAC PLASMA WAND | GEI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| June 28, 2001 | K011083 | ARTHROCARE SYSTEM 2000 CONTROLLER, CABLE, FOOTSWITCH, POWER CORD & ARTHROCARE ARTHROWAND | HRX | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| June 19, 2001 | K011634 | ARTHROCARE CONTROLLER, MODEL H2000; ARTHROCARE CABLE, MODEL H0970-02; FOOTSWITCH, MODEL H2000-04; POWERCORD, MODEL H2000 | GEI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| December 11, 2000 | K001160 | VERSABOND BONE CEMENT | LOD | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 17, 2000 | K001904 | ARTHROCARE FLOW CONTROL UNIT | GEI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 17, 2020 | 86290 | Class II | Ongoing | Speed Stitch Needle Cassette | Due to a supplier error where a portion of the raw material was inadvertently mixed. As a result, some needles may be made of commercially pure titanium as opposed to 304 stainless steel which does not meet the specification and could potentially break during use. | accessdata.fda.gov |
| February 21, 2019 | 85321 | Class II | Terminated | Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971 | The voluntary recall is being initiated due to a manufacturing error resulting in incorrect upper jaw dimensions, and the upper jaw could potentially disengage or detach during use. | accessdata.fda.gov |
| March 3, 2016 | 73525 | Class II | Terminated | TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ MicroDebrider 0.8 mm REF Q6000-01; TOPAZ EPF MicroDebrider 0.8 mm 45 REF Q6002-01 | During functional testing of devices after real time aging, it was determined that product failed to meet shelf-life at the expiration date indicated on the product labels. | accessdata.fda.gov |
| October 26, 2015 | 72789 | Class II | Terminated | Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in spinal procedures. | There is cracking in the tray when the device is snapped into place. The crack is through the full thickness of the tray, compromising the sterile barrier. | accessdata.fda.gov |
| June 2, 2015 | 71468 | Class II | Terminated | EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable Product Usage: PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in oto | Wands inspected with the adaptor fixture were released to the field not meeting the dielectric (Hipot) specifications. | accessdata.fda.gov |
| May 15, 2015 | 71311 | Class II | Terminated | EVAC 70 XTRA with Integrated Cable REF EICA5872-01 Product Usage: PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) sur | Potential component failure causing device inoperability | accessdata.fda.gov |
| February 20, 2015 | 70594 | Class II | Terminated | Coblator II System, 120V. Product Usage: The Coblator II (Model RF8000E) is a bipolar, radiofrequency electrosurgical system designed for use in otorhinolaryngology (ENT) surgery. The system consists of the following com | The recalling firm was notified by the contract manufacturer that they had reversed the L2, L3, L4, or L5 components on the P/N09010 RoHS boards of the Coblator II Controller (Model RF8000E). | accessdata.fda.gov |
| October 27, 2014 | 69667 | Class II | Terminated | Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger Switches and Model Number ASHA5050-01: Ambient KVac Wand with Integrated Finger Switches. The Wands are indicated for the resection, ablation, and c | Potential breach of sterile barrier due to defective product tray. | accessdata.fda.gov |
| December 9, 2013 | 67087 | Class II | Terminated | Arthrocare SPORTS MEDICINE, Knot Pusher, REF 25-3011, LOT #1049402, CON 1, 2013-10, NON-STERILE, Rx only | A sharp edge on the cannulated tip of the device may damage or cut a suture. | accessdata.fda.gov |
| May 11, 2011 | 59978 | Not yet classified | Terminated | ArthroCare brand MiniMagnum Knotless Fixation Implant Device with Inserter Handle Plus SpeedStitch Magnum Wire Suture Cartridge; Catalog Number: OM-6007; Product is manufactured and distributed by ArthroCare Corporation, | ArthroCare initiated the recall of one lot of the MiniMagnum Knotless Implant Fixation Device where the incorrect diver block was packed with the implant. | accessdata.fda.gov |
| September 30, 2010 | 57830 | Not yet classified | Terminated | ArthroCare Opus SpeedLock Knotless Fixation Device; Catalog Number: OM-7500. | During surgical procedure the product has the potential for separation of the plug guide. Separation of the plug guide may compromise the ability of the inserter to fully drive the implant completely into the bone, which may also compromise the ability to tension the suture properly. | accessdata.fda.gov |
| August 5, 2008 | 52722 | Not yet classified | Terminated | ArthroWand Saber 30 with Integrated Cable wand, Catalog number AC4330-01, Manufactured by ArthroCare Corporation, Sunnyvale, CA | Potential Sterility Loss-- Due to wearing or puncture in the Tyvek lid, the product may lose sterility. | accessdata.fda.gov |
| April 9, 2008 | 48731 | Not yet classified | Terminated | ArthroCare ArthroWand Covator with Integrated Cable Wand, Catalog number AC4340-01. The product is a medical device for human use in electrosurgical cutting and coagulation accessories. Product is indicated for resection | Product is not secure in packaging, and movement may damage the product or render it non-sterile. | accessdata.fda.gov |
| January 31, 2008 | 46962 | Not yet classified | Terminated | ArthroCare brand Topaz XL ArthroWand with Integrated Cable Wand, Catalog Number: AC4045-01; Product is manufactured and distributed by ArthroCare Corporation, Sunnyvale, CA - Sterile Surgical Device. Product is indicated | Devices for which sterility may be compromised as evidenced by punctures in the plastic tray during shipping. The risk to the patient is a potential infection subsequent to the surgical procedure. | accessdata.fda.gov |
| June 28, 2006 | 35878 | Not yet classified | Terminated | OPUS SpeedStitch Suture Cartridge with Magnumwire, a component of the OPUS MiniPlus Implant Set, for use in placement of sutures through soft tissue in endoscopic and other limited access procedures. | The product may lose sterility due to omission of the final pouch seal. | accessdata.fda.gov |
| June 7, 2006 | 35648 | Not yet classified | Terminated | ArthroCare brand OPUS Smartstitch Suture Cartridge, Catalog Number: OM-8071; Product is distributed by ArthroCare Corporation, 680 Vaqueros Ave., Sunnyvale, CA 94085 | Potential loss of product sterility due to breach of pouch seal. | accessdata.fda.gov |
| July 12, 2005 | 32688 | Not yet classified | Terminated | ArthoCare Caps-Lock Cannula, polypropylene 70 mm cannula sterile, in double pouch, 10 pouches per chipboard box, lot code 1905. | Potential loss of product sterility due to breach of outer and inner seal packages, which may result in infection | accessdata.fda.gov |
Compare with other makers
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- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Balloon, Epistaxis
Updated March 30, 2026. 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.