Source: http://www.readbag.com/accessdata-fda-cdrh-docs-pdf10-k102262
Timestamp: 2019-07-22 07:33:27
Document Index: 184709949

Matched Legal Cases: ['art 807', 'art 801', 'art 820', 'art 801', 'art 807', 'art 803', 'art 21']

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OCT 2:1 2010
ArthroCare®Corporation ArthroCare®SpartanTMPEEK Suture Implant General Information Submitter Name/Address:
ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-3523 2951580 Valerie Defiesta-Ng Director, Regulatory Affairs August 9, 2010 ArthroCare Spartan PEEK Suture Implant Screw, Fixation, Bone Smooth or Threaded Metallic Bone Fixation Fastener (21 CFR 888.3040) Class II, 21 CFR 888.3040 Product Code MBI
Establishment Registration Number: Contact Person: Date Prepared: Device Description Trade Name: Generic/Common Name: Classification Name: Device Classification:
Predicate Devices ArthroCare Opus Magnum Speedscrew Knotless Fixation Device Arthrocare Opus Speedscrew System ArthroCare Titan Ti Suture Anchor ArthroCare Titan Ti Suture Anchor System
K081893 (cleared 10/02/08)
K100457 (cleared 03/1 9/1 0)
K092133 (cleared 11/05/09) K10l 184 (cleared 05/18/10)
Product Description The ArthroCare Spartan PEEK (polyether-etherketone) Suture Implant is a fully-threaded, corkscrew shape anchor available in a 5.5mm diameter size. The suture anchor comes preconfigured with MagnumWiree sutures for traditional knot tying and is mounted on a disposable delivery driver. The device is supplied sterile. Associated Class I instruments for installation and removal of the implant are available separately. Together, the Spartan suture anchor and instrumentation will be known as the ArthroCare Spartan PEEK Suture Implant System.
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Intended Uses/Indications for Use The ArthroCare Spartan PEEK Suture Implant 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-labral 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 reattachment 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 Substantial Equivalence In establishing substantial equivalence to the predicate devices, ArthroCare compared the intended use, device design, technology, and device components of the subject device with the predicate devices. Additionally, bench performance testing has been completed to demonstrate the substantial equivalence of the ArthroCare Spartan PEEK Suture Implant to the predicate Speedscrew implant in accordance with FDA Guidance Document Testing for Bone Anchors. The in vitro testing performed involved insertion of the anchors in a simulated human bone substrate followed by both ultimate strength and cyclic loading tests. The performance testing and device comparison demonstrate that the subject device is substantially equivalent to the predicate device, and is safe and effective for its intended use.
The ArthroCare Spartan PEEK Suture Implant, as described in this premnarket notification 510O(k), is substantially equivalent to the predicate devices.
10903 New Hampshire Avenue Document Control Room -W066-0.609 Silver Spring, MD 20993-0002
ArthoCare Corporation % Ms. Valerie Defiesta-Ng Director, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085 Re: K102262 Trade/Device Name: ArthoCare® Spartan T M PEEK Suture Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: August 92010 Received: August 10, 201 0 Dear Ms. Defiesta-Ng: We have reviewed your Section 5 10(k) premnarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRHI does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) info either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts $00 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic produci radiation control provisions (Sections 53 1-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda. pov/AboLutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.htrn for the Center for Devices and Radiological Health's (CDRI-'s) Office of Compliance. Also, please note the regulation entitled, &quot;Misbranding by reference to premarket notification&quot; (2 1 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CER Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.jgov/MedicalDevic--s/ResourcesforYou/Industry/default.htm. Sincerely yours,
Mark/lelkrsiA~ Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure
51 0(k) Number (if known):
ArthroCareo Spartan TMPEEK Suture Implant
The ArthroCare Spartan PEEK Suture Implant 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 shiftlcapsule-labral reconstruction, biceps tenodesis, and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, and midfoot reconstruction Foot: H-allux valgus reconstruction Elbow: Tennis elbow repair, biceps tendon reattachment 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
X (Part 21 CFR.801 Subpart D)
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510(k) Number K1(024
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