ArthroCare Corporation
Austin, TX, US
ArthroCare Corporation appears in FDA device records in Austin, TX. FDA records list 149 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 19 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to ArthroCare Corporation carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- ArthroCare Medical Corporationenforcement report, recall
510(k) clearance history
Showing 50 of 149FDA records hold 149 510(k) clearances for ArthroCare Corporation between 1995 and 2026. The busiest year on record is 2000, with 12. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 2 |
| 1996 | 6 |
| 1997 | 3 |
| 1998 | 2 |
| 1999 | 2 |
| 2000 | 12 |
| 2001 | 7 |
| 2002 | 11 |
| 2003 | 8 |
| 2004 | 2 |
| 2005 | 5 |
| 2006 | 8 |
| 2007 | 11 |
| 2008 | 9 |
| 2009 | 8 |
| 2010 | 8 |
| 2011 | 6 |
| 2012 | 2 |
| 2013 | 9 |
| 2014 | 6 |
| 2015 | 4 |
| 2016 | 5 |
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 2 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 1 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K254122 | FLOW FLEXTEND Wand (72290039) | GEI | Substantially Equivalent | |
| K253680 | LYNX COBLATION Laryngeal Wand (72290254) | GEI | Substantially Equivalent | |
| K240964 | FLOW 90? Wand | GEI | Substantially Equivalent | |
| K232290 | INTELLIO SHIFT System | GEI | Substantially Equivalent | |
| K230914 | ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146) | GEI | Substantially Equivalent | |
| K220563 | Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ COBLATION System | GEI | Substantially Equivalent | |
| K210423 | Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand | GEI | Substantially Equivalent | |
| K202006 | ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation System | GEI | Substantially Equivalent | |
| K192027 | WEREWOLF COBLATION System, COBLATION HALO Wand | GEI | Substantially Equivalent | |
| K183346 | FLOW 90 Wand | GEI | Substantially Equivalent | |
| K180848 | AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches | GEI | Substantially Equivalent | |
| K172165 | Q-Fix Suture Anchor | MBI | Substantially Equivalent | |
| K163142 | SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader | GAT | Substantially Equivalent | |
| K161481 | Ambient HipVac 50 Wand with Integrated Finger Switches | GEI | Substantially Equivalent | |
| K162126 | Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KVac ICW) | GEI | Substantially Equivalent | |
| K162074 | Werewolf RF20000 Controller, FLOW 50 Wand | GEI | Substantially Equivalent | |
| K153186 | Adjustable Fixation Device | MBI | Substantially Equivalent | |
| K153675 | Paragon T2 Wand with Integrated Cable | GEI | Substantially Equivalent | |
| K153313 | SpeedLock Knotless Fixation System | MBI | Substantially Equivalent | |
| K143235 | RF20000a Controller, FLOW 50 Wand | GEI | Substantially Equivalent | |
| K151897 | MultiFIX® P Knotless Fixation Device | MBI | Substantially Equivalent | |
| K151660 | MultiFIX S Knotless Fixation System | MBI | Substantially Equivalent | |
| K142999 | EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP Plasma Wand with Integrated Cable | GEI | Substantially Equivalent | |
| K140992 | ARTHROCARE NASASTENT CMC NASAL DRESSING | LYA | Substantially Equivalent | |
| K140521 | TOPAZ EZ MICRODEBRIDER COBLATION WAND WITH INTEGRATED FINGER SWITCH | GEI | Substantially Equivalent | |
| K140604 | MULTIFIX S KNOTLESS FIXATION SYSTEM | MBI | Substantially Equivalent | |
| K133606 | N8TIVE ACL ANATOMIC RECONSTRUCTION SYSTEM, N8TIVE ACL FEMORAL IMPLANT, N8TIVE ACL TIBIAL IMPLANT, VARIOUS CLASS I ANCILL | MBI | Substantially Equivalent | |
| 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 | |
| K131709 | SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT | LRC | Substantially Equivalent | |
| 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 | MBI | Substantially Equivalent | |
| K132590 | 5.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, 6.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, INSERTION GUIDE WITH OBTURATOR, TA | MBI | Substantially Equivalent | |
| K132099 | ARTHROCARE COBLATOR IQ DLR SPINEWAND, ARTHROCARE COBLATOR IQ DLG SPINEWAND | GEI | Substantially Equivalent | |
| K131205 | ARTHROCARE HEAD AND NECK COBLATION WAND | GEI | Substantially Equivalent | |
| K122652 | ARTHROCARE TURBINATOR WAND | GEI | Substantially Equivalent | |
| K123353 | CIQ CONTROLLER, CIQ WANDS | GEI | Substantially Equivalent | |
| K130196 | SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DR | MBI | Substantially Equivalent | |
| K123240 | SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT | MBI | Substantially Equivalent | |
| K120943 | SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT SPEEDLOCK HIP DRILL SPEEDLOCK HIP GUIDE CROWN TIP SPEEDLOCK HIP PATHFINDER | MBI | Substantially Equivalent | |
| K120096 | MULTIFIX P KNOTLESS FIXATION DEVICE | MBI | Substantially Equivalent | |
| K111044 | SPEEDLOCK KNOTLESS FIXATION DEVICE; 3.0MM DRILL; SHARP TIPPED OBTURATOR; LOW PROFILE DRILL GUIDDE | MBI | Substantially Equivalent | |
| K111399 | SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75 | MBI | Substantially Equivalent | |
| K111397 | TITAN TI SUTURE ANCHOR SYSTEM | MBI | Substantially Equivalent | |
| K110781 | 5.5 / 6.5MM SPARTAN PEEK SURTURE IMPLANT WITH #2 MAGNUMWIRE / WITH NEEDLES, EXTRACTION TOOL, 5.5 / 6.5MM PUNCH TAP | MBI | Substantially Equivalent | |
| K110183 | ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE | NDN | Substantially Equivalent | |
| K110164 | 5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL | MBI | Substantially Equivalent | |
| K101437 | SPEEDFIX SUTURE SYSTEM | MBI | Substantially Equivalent | |
| K102262 | ARTHOCARE SPARTAN PEEK SUTURE IMPLANT SYSTEM; PUNCH TAP ; EXTRACTION TOOL | MBI | Substantially Equivalent | |
| K100479 | PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE | NDN | Substantially Equivalent | |
| K101448 | OPUS SPEEDSCREW SYSTEM | MBI | Substantially Equivalent | |
| K101184 | TITAN TI SUTURE ANCHOR SYSTEM, MODELS 22-9055, 22-9055N, 22-9065, 22-9065N, 22-9022, 22-9005,, 22-9006 | MBI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006524618 | 3010813691 | ArthroCare Corporation | 7000 W William Cannon Dr, Austin, TX 78735 US | 2026 | and 11 more, listed in full below |
| 3012358417 | 3012358417 | Arthrocare Corporation | B32.1, St2, Coyol Alajuela 20101 CR | 2026 | and 32 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NBHAccessories, Arthroscopic
- LYUAccessory, Surgical Apparel
- HRXArthroscope
- EMXBalloon, Epistaxis
- HTWBit, Drill
- GFGBit, Surgical
- LODBone Cement
- MBBBone Cement, Antibiotic
- HXYBrace, Drill
- GEACannula, Surgical, General & Plastic Surgery
- NDNCement, Bone, Vertebroplasty
- KQZComponent, Traction, Non-Invasive
- NADDressing, Wound, Occlusive
- FASElectrode, Electrosurgical, Active, Urological
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- OCWEndoscopic Tissue Approximation Device
- HWBExtractor
- MAIFastener, Fixation, Biodegradable, Soft Tissue
- MBIFastener, Fixation, Nondegradable, Soft Tissue
- MQVFiller, Bone Void, Calcium Compound
- HXKHolder, Needle; Orthopedic
- OARInjector, Vertebroplasty (Does Not Contain Cement)
- HXPInstrument, Bending Or Contouring
- LRCInstrument, Ent Manual Surgical
- MDMInstrument, Manual, Surgical, General Use
- FEIInstrument, Special Lens, For Endoscope
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- KDDKit, Surgical Instrument, Disposable
- HXLMallet
- FTMMesh, Surgical
- OWYMesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
- ORQMesh, Surgical, Deployer
- GEYMotor, Surgical Instrument, Ac-Powered
- QFCNegative Pressure Wound Therapy Device For Reduction Of Wound Complications
- OMPNegative Pressure Wound Therapy Powered Suction Pump
- LXHOrthopedic Manual Surgical Instrument
- HWQPasser
- HTYPin, Fixation, Smooth
- HXBProbe
- GXIProbe, Radiofrequency Lesion
- FMPProtector, Skin Pressure
- KGSRetention Device, Suture
- HRRScissors, Orthopedic, Surgical
- HWCScrew, Fixation, Bone
- OLLSeptal Stapler/Absorbable Staples
- GAESnare, Surgical
- LYASplint, Intranasal Septal
- JDRStaple, Fixation, Bone
- GATSuture, Nonabsorbable, Synthetic, Polyethylene
- HXGTamp
- HWXTap, Bone
- FSMTray, Surgical, Instrument
- EKZUnit, Electrosurgical, And Accessories, Dental
- KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)
- HTNWasher, Bolt Nut
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2999-2020 | 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. | Class II | Open, Classified | |
| Z-3000-2020 | 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. | Class II | Terminated | |
| Z-1321-2016 | 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. | Class II | Terminated | |
| Z-0623-2016 | 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. | Class II | Terminated | |
| Z-2105-2015 | 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 otorhinolaryngology (ENT) surgery including: adenoidectomy, cysts, head, neck, oral, and sinus surgery, mastoidectomy, myringotomy with effective hemorrhage control, nasal airway obstruction be reduction of hypertrophic nasal turbinates, nasopharyngeal/laryngeal indications including tracheal procedures, laryngeal polypectomy, and laryngeal lesion debulking, neck mass, papilloma keloids, submucosal palatal shrinkage, submucosal tissue shrinkage, tonsillectomy (including palatine tonsils), traditional uvulopalatoplasty (RAUP), tumors, and tissue in the uvula/soft palate for the treatment of snoring. It is intended for procedures using a conductive media, such as normal saline or Ringers lactate. | Wands inspected with the adaptor fixture were released to the field not meeting the dielectric (Hipot) specifications. | Class II | Terminated | |
| Z-1833-2015 | PROcise XP Wand with Integrated Cable REF EICA8872-01 Product Usage: PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: adenoidectomy, cysts, head, neck, oral, and sinus surgery, mastoidectomy, myringotomy with effective hemorrhage control, nasal airway obstruction by reduction of hypertrophic nasal turbinates, nasopharyngeal/laryngeal indications including tracheal procedures, laryngeal polypectomy, and laryngeal lesion debulking, neck mass, papilloma keloids, submucosal palatal shrinkage, submucosal tissue shrinkage, tonsillectomy (including palatine tonsils), traditional uvulopalatoplasty (RAUP), tumors, and tissue in the uvula/soft palate for the treatment of snoring. It is intended for procedures using a conductive media, such as normal saline or Ringers lactate. | Potential component failure resulting in inoperability | Class II | Terminated | |
| Z-1832-2015 | 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) surgery including: adenoidectomy, cysts, head, neck, oral, and sinus surgery, mastoidectomy, myringotomy with effective hemorrhage control, nasal airway obstruction by reduction of hypertrophic nasal turbinates, nasopharyngeal/laryngeal indications including tracheal procedures, laryngeal polypectomy, and laryngeal lesion debulking, neck mass, papilloma keloids, submucosal palatal shrinkage, submucosal tissue shrinkage, tonsillectomy (including palatine tonsils), traditional uvulopalatoplasty (RAUP), tumors, and tissue in the uvula/soft palate for the treatment of snoring. It is intended for procedures using a conductive media, such as normal saline or Ringers lactate. | Potential component failure causing device inoperability | Class II | Terminated | |
| Z-1323-2015 | 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 components: an electrosurgical radiofrequency controller, a reusable, non-sterile Power Cord; a reusable, non-sterile Foot Control; a reusable, non-sterile Flow control Valve Unit; a reusable, non-sterile flow control cable; a single use, disposable, sterile Wand. The Coblator II is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery. | 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). | Class II | Terminated | |
| Z-0579-2015 | 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 coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures. | Potential breach of sterile barrier due to defective product tray. | Class II | Terminated | |
| Z-0652-2014 | 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. | Class II | Terminated | |
| Z-0049-2012 | 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, Sunnyvale, CA The MiniMagnum Knotless Fixation Device is indicated for use in fixation of soft tissue to bone. Examples of such procedures include: Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-Iabral reconstruction, biceps tenodesis and deltoid repair. Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction Foot: Hallux valgus reconstruction Elbow: Tennis elbow repair, biceps tendon attachment Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions. | ArthroCare initiated the recall of one lot of the MiniMagnum Knotless Implant Fixation Device where the incorrect diver block was packed with the implant. | Terminated | ||
| Z-1952-2011 | 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. | Terminated | ||
| Z-1900-2009 | 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. | Terminated | ||
| Z-2309-2008 | 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, ablation and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures. | Product is not secure in packaging, and movement may damage the product or render it non-sterile. | Terminated | ||
| Z-1657-2008 | 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 for ablation and debridement of tendons in orthopedic procedures. | 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. | Terminated | ||
| Z-1312-06 | 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. | Terminated | ||
| Z-1187-06 | ArthroCare brand OPUS Smartstitch Magnum Wire Suture Cartridge, Catalog Number: OM-8075; Product is distributed by ArthroCare Corporation, 680 Vaqueros Ave., Sunnyvale, CA 94085 | Potential loss of product sterility due to breach of pouch seal. | Terminated | ||
| Z-1186-06 | 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. | Terminated | ||
| Z-1043-05 | 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 | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain