MINI TIGHTROPE REPAIR KIT, MODEL AR-8911DS

{0}------------------------------------------------ K061925 page 1 of 2 # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Mini TightRope™ Repair Kit 0C1 3 1 2006 NAME OF SPONSOR: Arthrex, Inc. 1370 Creekside Boulevard Naples, Florida 34108-1945 510(K) CONTACT: Sally Foust, RAC Regulatory Affairs Project Manager Telephone: (239) 643-5553 ext. 1251 FAX: (239) 598-5539 TRADE NAME: Mini TightRope™ Repair Kit COMMON NAME: Button/Suture DEVICE PRODUCT CODE/CLASSIFICATION: HTN: Single/multiple component metallic bone fixation appliances and accessories: 21 CFR 888.3030 ## PREDICATE DEVICES K041189: TRIM-IT Family (Arthrex, Inc.) K052776: TightRope AC Device (Arthrex, Inc.) K043248: TightRope Syndesmosis Device (Arthrex, Inc.) # DEVICE DESCRIPTION AND INTENDED USE The Mini TightRope™ Repair Kit is designed as two differently sized metal buttons and FiberWire™ suture. The buttons are pre-threaded with FiberWire suture, looped twice through the buttoriholes. A pull-through FiberWire suture is looped through one button. The Mini TightRope™ Kit is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. {1}------------------------------------------------ page 2 of 2 Specifically, the Arthrex Mini TightRope Repair Kit is intended to provide fixation during the healing process following: - 1) Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament (DRUL) disruptions; - 2) Tarasometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and - 3) Hallux Valgus reconstruction (correction) by providing for the reduction of 155 metatarsal - 200 metatarsal intermetatarsal angle. ## SUBSTANTIALLY EQUIVALENCE Arthrex has determined that the Mini TightRope™ Repair Kit is substantially equivalent to the predicate devices where basic features and intended uses are the same. Any design differences between the Arthrex Mini TightRope™ Repair Kit when compared to predicate devices used in the standard medical practice for the treatment of DRUL disruptions in syndesmotic trauma, TMT (Lisfranc) injuries, and reduction for the 1st metatarsal - 2nd metatarsal intermetatarsal angle following Hallux Valgus reconstruction (correction) are considered minor and do not raise any questions concerning safety and effectiveness. Any differences have been found to have no apparent effect on the performance, function, or intended use of the device. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features an abstract image of an eagle with its wings spread. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Arthrex, Inc. % Ms. Sally Foust, RAC Regulatory Affairs Project Manager 1370 Creekside Boulevard Naples, Florida 34108 0C7 3 1 2006 Re: K061925 Trade/Device Name: Mini TightRope™ Repair Kit Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HTN Dated: September 27, 2006 Received: September 28, 2006 Dear Ms. Foust: 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ Page 2 - Ms. Sally Foust, RAC This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 240-276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. for Pehns Mark N. Malkerson Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Indications for Use 510(k) Number (if known): K061925 Device Name Mini TightRope™ Repair Kit #### Indications for Use: The Mini TightRope™ Repair Kit is interided as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. Specifically, the Arthrex Mini TightRope™ Repair Kit is intended to provide fixation during the healing process following: - 1) Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament (DRUL) disruptions; - 2) Tarasometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and - 3) Hallux Valgus reconstruction (correction) by providing for the reduction of 1st metatarsal -2nd metatarsal intermetatarsal angle. | Prescription Use ___X__ | | |----------------------------|---| | (Per 21 CFR 801 Subpart D) | A | AND/C)R Over-The-Counter Use (21 CFR 801 Subpart C) (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 General, Restorative, and Neurological Devices 51 Ko 61925