SPEEDLOCK KNOTLESS FIXATION DEVICE; 3.0MM DRILL; SHARP TIPPED OBTURATOR; LOW PROFILE DRILL GUIDDE

{0}------------------------------------------------ K111044 #1/2 ### 510(K) SUMMARY AUG - 9 2011 ARTHROCARE CORPORATION SPEEDLOCK KNOTLESS FIXATION SYSTEM #### General Information Submitter Name/Address: ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-3523 Establishment Registration No .: Contact Person: 2951580 Laura N. Kasperowicz Sr. Manager, Regulatory Affairs Date Prepared: April 14, 2011 Device Description Model Name: Generic/Common Name: Classification Name: Device Classification: Model Name: Generic/Common Name: Model Name: Generic/Common Name: Model Name: Generic/Common Name: Model Name: Generic/Common Name: Model Name: Generic/Common Name: Predicate Devices Opus® SpeedLock® Knotless Fixation Device SpeedLock Knotless Fixation Device Bone Anchor, Fastener, Fixation, Soft Tissue Fastener, Fixation, Nondegradeable, Soft Tissue Class II per 21 CFR 888.3040, Product code: MBI Drill, 3.0 mm Bone Drill PathFinder® Obturator Bone Hole Locator Sharp-Tipped Obturator Bone Hole Locator Drill Guide, 3.5mm High Visibility Drill Guide Drill Guide, 3.5mm Low Profile Drill Guide K090615 (June 3, 2010) #### Product Description The SpeedLock Knotless Fixation Device is a bone anchor system with inserter handle designed for specific indications in arthroscopic and orthopedic procedures. {1}------------------------------------------------ K111044 ** ## 510(K) SUMMARY #### Indications For Use The SpeedLock Knotless Fixation Device with inserter 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 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 #### Substantial Equivalence By definition, substantial equivalence means that a device has the same intended use and technical characteristics as the predicate device, or has the same intended use and different technological characteristics, but can be demonstrated to be as safe and effective as the predicate device. The SpeedLock Knotless Fixation device design and technology is substantially equivalent to the existing SpeedLock Knotless Fixation Device [K090615]. Side by side comparison bench testing was performed on the proposed and predicate device per the US FDA Guidance Document for Testing Bone Anchors. The differences between the SpeedLock and the predicate device do not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the materials are well characterized and have been used in predicate devices with similar indications. The proposed device, as designed, is as safe and effective as predicate devices. #### Summary and Reason for 510k Notification The purpose of this 510(k) is to notify the Food and Drug Administration of a proposed modification to an existing product. The proposed device, the SpeedLock Knotless Fixation Device is substantially equivalent to the SpeedLock Knotless Fixation Device originally cleared under K090615. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure with three curved lines representing its wings or feathers. The symbol is stylized and modern in appearance. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002 Arthrocare Corporation % Ms. Laura Kasperowicz Senior Manager, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085-3523 AUG - 9 2011 Re: K111044 Trade/Device Name: Speedlock® Knotless Fixation Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: June 30, 2011 Received: July 05, 2011 Dear Ms. Kasperowicz: We have reviewed your Section 510(k) premarket 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: CDRH does not evaluate information related to contract liability warrantics. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into 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 800 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 {3}------------------------------------------------ # Page 2 – Ms. Laura Kasperowicz Page 2 - RTS. 13. 21 CFR Part 820); and if applicable, the electri iems (QS) regulation (2 531-542 of the Act); 21 CFR Page 2 – Ms. Laura Kasperwies forth in the quality systems (QS) regulation (21 (2) result in the Act), 20 (2) 1) (20) Provinsion (20) forth in the quality systems (Sections 531-542 of the Act (20 Tores) ( forth in the quality systems (QS) (Sections 31) - 9 (Section (21 CFR Pari 801), please product radiation conrol province on our leving resultant (21 Crity of the presenter (2 ordinion confor provise on our labeling regallation (21 CFR Pail 800).phfor Fryour desire specific advice on our label (2020). If your desire specificadires (CDRLF) Offices O groudes specific advice for your devices of Collectific of Compliantes. All official If you desire specifica de Collers (CDP) CV CTV CTT Crostino C. Allery Party Party Party if you desire specific and real to contributed to Compliance. Also, post the Centre in Devices and Palibir (CDR se of Complimor (1) (1) 1) (1) 1) (1) 1) 1) (1) 1) 1) 10 (1) 1 3 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - ited on regulation entitled, "many of an ereporting of acres of the CDRH's Office Bor 971. For questions regulars regulations (demail. CFR Part 803), please goivers of Pos Strict 803), please go to - - nttp://www.fda.gov.wikips/Division of Postmal of Postmal of the Act from the Act from the Act from the Act from the Act from the Act from the Act from the May of Survey of As of Surveillance and Stoners and Consumer Assistance as issistance at is toll-liee You may obtain other general informational and Consumer Assistance at is toll-live number You may obtain of Small Manufacturers, Inc. than and see at its Internet address You may obtain only got You may of Small Manufacturers, internet address (800) 638-2041 or (301) 796-7100 or at is Internet address (800) 638-2041 or (301) 796-7100 or at is Incessor You/Industry/de Sincerely yours, erely yours, for Peter Hunter me or Mark N. Melkerson Director Director Division of Surgical, Orthopedic Wision and Restorative Devices and Restoraice Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # INDICATIONS FOR USE STATEMENT | 510(k) Number: | K 111044 | |----------------------|-------------------------------------| | Device Name: | SpeedLock® Knotless Fixation System | | Indications for Use: | | The SpeedLock 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-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 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 Prescription Use (Part 21 CFR 801 Subpart D) AND/OR X Over-The-Counter Use (21 CFR 801 Subpart C) NO (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices KL 111/044 page v 510(k) Number