← Product Code [HTN](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTN) · K071978 # MINI TIGHTROPE FT REPAIR KIT (K071978) _Arthrex, Inc. · HTN · Aug 15, 2007 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTN/K071978 ## Device Facts - **Applicant:** Arthrex, Inc. - **Product Code:** [HTN](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTN.md) - **Decision Date:** Aug 15, 2007 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Mini TightRope FT Repair 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. Specifically, the Mini TightRope FT 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. ## Device Story The Mini TightRope FT Repair Kit is a surgical fixation system consisting of one metal button, one bioabsorbable suture anchor, and FiberWire suture. The components are pre-threaded with the suture looped twice. The device is used by surgeons in an operating room setting to provide bone fixation during the healing process for small bone fragments, syndesmotic trauma, Lisfranc injuries, and Hallux Valgus correction. It serves as an adjunct to other fixation systems (plates/rods) or as a standalone solution where screws are not indicated. The device provides mechanical stabilization of bone or soft tissue, facilitating reduction and healing. ## Clinical Evidence No clinical data provided; substantial equivalence is based on design and intended use similarities to the predicate device. ## Technological Characteristics System includes a metal button, bioabsorbable suture anchor, and FiberWire suture. The device functions as a mechanical bone fixation appliance. No electronic, software, or energy-based components. ## Regulatory Identification Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system. ## Predicate Devices - Arthrex Mini TightRope Repair Kit ([K061925](/device/K061925.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K. 071978 page 12 Arthrex SPECIAL 510(k); Arthrex Mini TightFlope FT Repair Kit AUG 1-5 2007 | 4 510(k) Summary of Safety and Effectiveness | | |---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer/Distributor/Sponsor | Arthrex, Inc.
1370 Creekside Boulevard
Naples, FL 34108-1945 USA | | 510(k) Contact | Sally Foust, RAC
Regulatory Affairs Project Manager
Arthrex, Inc.
1370 Creekside Boulevard
Naples, FL 34108-1945 USA
Telephone: 239/643.5553, ext. 1251
Fax: 239/598.5508
Email: sfoust@arthrex.com | | Trade Name | Mini TightRope FT Repair Kit | | Common Name | Button / Anchor / Suture | | Product Code -Classification Name | HTN – Single/multiple component metallic bone fixation appliances and accessories | | Predicate Device | Arthrex Mini TightRope Repair Kit, K061925 | | Device Description and Intended Use | The Mini TightRopeTM FT Repair Kit is designed as one metal button, one bioabsorbable suture anchor, and one FiberWireTM suture. The button and anchor are pre-threaded with FiberWire looped twice.
The Mini TightRope FT Repair 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.
Specifically, the Mini TightRope FT 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 | | providing for the reduction of 1st metatarsal - 2nd metatarsal intermetatarsal angle. | | | Substantial Equivalence Summary | The Mini TightRope™ FT Repair Kit is substantially equivalent to the predicate Mini TightRope™ Repair Kit in which the basic features and intended uses are the same. Any differences between the Mini TightRope™ FT Repair Kit and the predicate Mini TightRope™ Repair Kit is considered minor and do not raise questions concerning safety and effectiveness. Based on the information submitted, Arthrex, Inc. has determined that the new Mini TightRope™ FT Repair Kit is substantially equivalent to the currently marketed predicate device. | {1}------------------------------------------------ page 12 Arthrex SPECIAL 510(k): Arthrex Mini TightfRope FT Repair Kit : . {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is oriented to follow the curve of the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 15 2007 Arthrex, Inc. % Ms. Sally Foust Regulatory Affairs Project Manager 1370 Creekside Boulevard Naples, Florida 34108-1945 > K071978 Trade/Device Name: Mini TightRope FT 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 & HWC Dated: July 13, 2007 Received: July 18, 2007 Dear Ms. Foust: Re: 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 {3}------------------------------------------------ ## Page 2 - Ms. Sally Foust 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. 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). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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, Barbene Buehup Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Arthrex SPECIAL 510(K): Arthrex Mini TightFlope FT Repair Kit Indications for Use 510(k) Number: Ko71978 Device Name: Mini TightRope FT Repair Kit The Mini TightRope FT Repair 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. Specifically, the Mini TightRope FT 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 18t metatarsal -2nd metatarsal intermetatarsal angle. Prescription Use _ X_ AND/OR Over-The-Counter Use (Per 21 CFR 801 Subpart D) (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 PAGE 1 of Division of Ger estorative. and Neurological I Mini TightRope FT Repair Kit 510(k) 7 of 41 510(k) Number K671978 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTN/K071978](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTN/K071978) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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