Company · US
Arthrocare Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 2026. Name variants (Inc, Corp, punctuation) are merged.
149510(k) clearances (2 in 12 months)
14recalls (0 in 12 months)
13recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 91 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 32 |
| HRX | Arthroscope | 8 |
| NDN | Cement, Bone, Vertebroplasty | 6 |
| FAS | Electrode, Electrosurgical, Active, Urological | 5 |
| HWC | Screw, Fixation, Bone | 5 |
| KOG | 3 | |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 2 |
| OCW | Endoscopic Tissue Approximation Device | 2 |
| EKZ | Unit, Electrosurgical, And Accessories, Dental | 1 |
| GEA | Cannula, Surgical, General & Plastic Surgery | 1 |
| GEY | Motor, Surgical Instrument, Ac-Powered | 1 |
| GXI | Probe, Radiofrequency Lesion | 1 |
| HXK | Holder, Needle; Orthopedic | 1 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 1 |
| LRC | Instrument, Ent Manual Surgical | 1 |
| LYA | Splint, Intranasal Septal | 1 |
| OAR | Injector, Vertebroplasty (Does Not Contain Cement) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 30, 2026 | K254122 | FLOW FLEXTEND Wand (72290039) ArthroCare Corporation | GEI |
| Mar 25, 2026 | K253680 | LYNX COBLATION Laryngeal Wand (72290254) ArthroCare Corporation | GEI |
| May 8, 2024 | K240964 | FLOW 90? Wand ArthroCare Corporation | GEI |
| Dec 11, 2023 | K232290 | INTELLIO SHIFT System ArthroCare Corporation | GEI |
| Jun 26, 2023 | K230914 | ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System ( ArthroCare Corporation | GEI |
| Sep 1, 2022 | K220563 | Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ C ArthroCare Corporation | GEI |
| Jun 24, 2021 | K210423 | Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand ArthroCare Corporation | GEI |
| Dec 18, 2020 | K202006 | ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation System ArthroCare Corporation | GEI |
| Dec 20, 2019 | K192027 | WEREWOLF COBLATION System, COBLATION HALO Wand ArthroCare Corporation | GEI |
| Jan 24, 2019 | K183346 | FLOW 90 Wand ArthroCare Corporation | GEI |
| May 1, 2018 | K180848 | AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches ArthroCare Corporation | GEI |
| Aug 17, 2017 | K172165 | Q-Fix Suture Anchor ArthroCare Corporation | MBI |
| Jan 6, 2017 | K163142 | SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedSt ArthroCare Corporation | GAT |
| Oct 21, 2016 | K161481 | Ambient HipVac 50 Wand with Integrated Finger Switches ArthroCare Corporation | GEI |
| Sep 29, 2016 | K162126 | Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KVac ICW) ArthroCare Corporation | GEI |
| Aug 22, 2016 | K162074 | Werewolf RF20000 Controller, FLOW 50 Wand ArthroCare Corporation | GEI |
| Jan 28, 2016 | K153186 | Adjustable Fixation Device Arthrocare Corp. | MBI |
| Jan 15, 2016 | K153675 | Paragon T2 Wand with Integrated Cable ArthroCare Corporation | GEI |
| Dec 11, 2015 | K153313 | SpeedLock Knotless Fixation System ArthroCare Corporation | MBI |
| Oct 23, 2015 | K143235 | RF20000a Controller, FLOW 50 Wand ArthroCare Corporation | GEI |
| Aug 6, 2015 | K151897 | MultiFIX® P Knotless Fixation Device ArthroCare Corporation | MBI |
| Jul 16, 2015 | K151660 | MultiFIX S Knotless Fixation System ArthroCare Corporation | MBI |
| Nov 19, 2014 | K142999 | EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated Cable ArthroCare Corporation | GEI |
| Jun 16, 2014 | K140992 | ARTHROCARE NASASTENT CMC NASAL DRESSING ArthroCare Corporation | LYA |
| Jun 10, 2014 | K140521 | TOPAZ EZ MICRODEBRIDER COBLATION WAND WITH INTEGRATED FINGER SWITCH ArthroCare Corporation | GEI |
| May 14, 2014 | K140604 | MULTIFIX S KNOTLESS FIXATION SYSTEM ArthroCare Corporation | MBI |
| Apr 1, 2014 | K133606 | N8TIVE ACL ANATOMIC RECONSTRUCTION SYSTEM, N8TIVE ACL FEMORAL IMPLANT, N8TIVE ACL TIBIAL IMPLANT, VARIOUS CLASS I ANCILL ArthroCare Corporation | MBI |
| Jan 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 ArthroCare Corporation | MBI |
| Oct 4, 2013 | K131709 | SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT Arthrocare Corp. | LRC |
| Sep 19, 2013 | K132513 | Q-FIX SUTURE ANCHOR,1.8MM AND 2.8MM / DRILL, DRILL GUIDE AND OBTURATOR,1.8MM AND 2.8MM /BONE PUNCH,2.8MM AND KNOT PUSHER ArthroCare Corporation | MBI |
| Sep 17, 2013 | K132590 | 5.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, 6.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, INSERTION GUIDE WITH OBTURATOR, TA ArthroCare Corporation | MBI |
| Aug 22, 2013 | K132099 | ARTHROCARE COBLATOR IQ DLR SPINEWAND, ARTHROCARE COBLATOR IQ DLG SPINEWAND ArthroCare Corporation | GEI |
| Aug 9, 2013 | K131205 | ARTHROCARE HEAD AND NECK COBLATION WAND ArthroCare Corporation | GEI |
| Jul 2, 2013 | K122652 | ARTHROCARE TURBINATOR WAND ArthroCare Corporation | GEI |
| Apr 5, 2013 | K123353 | CIQ CONTROLLER, CIQ WANDS ArthroCare Corporation | GEI |
| Feb 27, 2013 | K130196 | SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DR Arthrocare Corp. | MBI |
| Feb 14, 2013 | K123240 | SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT ArthroCare Corporation | MBI |
| Sep 21, 2012 | K120943 | SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT SPEEDLOCK HIP DRILL SPEEDLOCK HIP GUIDE CROWN TIP SPEEDLOCK HIP PATHFINDER ArthroCare Corporation | MBI |
| Mar 27, 2012 | K120096 | MULTIFIX P KNOTLESS FIXATION DEVICE ArthroCare Corporation | MBI |
| Aug 9, 2011 | K111044 | SPEEDLOCK KNOTLESS FIXATION DEVICE; 3.0MM DRILL; SHARP TIPPED OBTURATOR; LOW PROFILE DRILL GUIDDE ArthroCare Corporation | MBI |
| Jul 20, 2011 | K111399 | SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75 Arthrocare Corp. | MBI |
| Jul 12, 2011 | K111397 | TITAN TI SUTURE ANCHOR SYSTEM Arthrocare Corp. | MBI |
| May 27, 2011 | K110781 | 5.5 / 6.5MM SPARTAN PEEK SURTURE IMPLANT WITH #2 MAGNUMWIRE / WITH NEEDLES, EXTRACTION TOOL, 5.5 / 6.5MM PUNCH TAP Arthrocare Corp. | MBI |
| Feb 16, 2011 | K110183 | ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE Arthrocare Corp. | NDN |
| Feb 7, 2011 | K110164 | 5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL Arthrocare Corp. | MBI |
| Oct 29, 2010 | K101437 | SPEEDFIX SUTURE SYSTEM Arthrocare Corp. | MBI |
| Oct 21, 2010 | K102262 | ARTHOCARE SPARTAN PEEK SUTURE IMPLANT SYSTEM; PUNCH TAP ; EXTRACTION TOOL Arthrocare Corp. | MBI |
| Sep 21, 2010 | K100479 | PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE Arthrocare Corp. | NDN |
| Jun 21, 2010 | K101448 | OPUS SPEEDSCREW SYSTEM Arthrocare Corp. | MBI |
| May 18, 2010 | K101184 | TITAN TI SUTURE ANCHOR SYSTEM, MODELS 22-9055, 22-9055N, 22-9065, 22-9065N, 22-9022, 22-9005,, 22-9006 Arthrocare Corp. | MBI |
Newest 50 of 149.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 17, 2020 | ArthroCare Corporation Speed Stitch Needle Cassette Open, Classified |
HXK | K163142 |
| Feb 21, 2019 | ArthroCare Corporation Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971 Terminated |
GAT | K123268 |
| Apr 5, 2016 | ArthroCare Corporation 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 Terminated |
GEI | K080282 |
| Jan 8, 2016 | ArthroCare Corporation Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in spinal procedures. Terminated |
GEI | K063172 |
| Jul 18, 2015 | ArthroCare Corporation 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 Terminated |
GEI | K070374 K142999 |
| Oct 14, 2011 | ArthroCare Corporation 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 Ar Terminated |
HWC | K042584 |
| Apr 12, 2011 | ArthroCare Corporation ArthroCare Opus SpeedLock Knotless Fixation Device; Catalog Number: OM-7500. Terminated |
MBI | K090615 |
| Aug 30, 2009 | ArthroCare Corporation ArthroWand Saber 30 with Integrated Cable wand, Catalog number AC4330-01, Manufactured by ArthroCare Corporation, Sunnyvale, CA Terminated |
GEI | K030551 |
| Sep 19, 2008 | ArthroCare Corporation 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 i Terminated |
GEI | K033584 |
| Sep 16, 2008 | ArthroCare Corporation 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. Terminated |
HRX | K053567 |
| Aug 2, 2006 | ArthroCare Corporation 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. Terminated |
KOG | K022229 |
| Jun 27, 2006 | ArthroCare Corporation ArthroCare brand OPUS Smartstitch Magnum Wire Suture Cartridge, Catalog Number: OM-8075;
Product is distributed by ArthroCare Corporation, 680 Vaqueros Ave., Sunnyvale, CA 94085 Terminated |
KOG | K022229 |
| Jun 27, 2006 | ArthroCare Corporation ArthroCare brand OPUS Smartstitch Suture Cartridge, Catalog Number: OM-8071;
Product is distributed by ArthroCare Corporation, 680 Vaqueros Ave., Sunnyvale, CA 94085 Terminated |
KOG | K022229 |
| Jul 22, 2005 | ArthroCare Corporation ArthoCare Caps-Lock Cannula, polypropylene 70 mm cannula sterile, in double pouch, 10 pouches per chipboard box, lot code 1905. Terminated |
GEA | None listed |