The Arthrex Mini TightRope and Mini TightRope FT are intended as adjuncts in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as adjuncts in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.

Specifically, the Arthrex Mini TightRope and the Mini TightRope FT are intended to provide fixation during the healing process following:

Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament (DRUL) disruptions;
Tarsometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and
Hallux Valgus reconstruction (correction) by providing for the reduction of 1st metatarsal -2nd metatarsal intermetatarsal angle.

The Arthrex Mini TightRope and the Mini TightRope FT, when used for fixation of bone-to-bone or soft-tissue-to-bone, are intended as fixation posts, distribution bridges, or for distributing suture tension over areas of ligament or tendon repair. Specifically, the Arthrex Mini TightRope and the Mini TightRope FT are indicated for Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the healing process of the reconstruction of the ligament at the base of the thumb metacarpal by providing stabilization between the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.

Device Description

The Mini TightRope is designed as either two metal buttons with a pre-threaded FiberWire suture or as one metal button, one bioabsorbable suture anchor with one pre-threaded FiberWire suture.

AI/ML Overview

The provided text is a 510(k) summary for the Arthrex Mini TightRope device. It focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance and does not contain information about acceptance criteria or specific study results to prove device performance in the context of AI/machine learning.

Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and study results, as this type of data is not present in the provided document. The document describes a medical device, its intended use, and its substantial equivalence to other devices, which is a regulatory and functional description rather than a performance evaluation with quantifiable metrics against acceptance criteria.

The information you are asking for, such as sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, are characteristic of studies evaluating AI/machine learning medical devices, which this document does not describe.

Summary

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12090 / Di

دنجه

AUG 0 62009

5 I 0(k) Summary of Safety and Effectiveness

Manufacturer/Distributor/Sponsor	Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA
510(k) Contact	Sally Foust, RACRegulatory Affairs Project ManagerArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 1251Fax: 239/598.5508Email: sfoust@arthrex.com
Trade Name	Mini TightRope
Common Name	Button / Anchor / Suture
Product Code -ClassificationName	HTN - Single/multiple component metallic bone fixation appliancesand accessories
Predicate Device	Mini TightRope Repair Kit, K061925Mini TightRope FT Repair Kit, K071978ACL RetroConstruction Button Kit, K031666
DeviceDescription andIntended Use	The Mini TightRope is designed as either two metal buttons with apre-threaded FiberWire suture or as one metal button, onebioabsorbable suture anchor with one pre-threaded FiberWire suture.
	The Arthrex Mini TightRope and Mini TightRope FT are intended asadjuncts in fracture repair involving metaphyseal and periarticularsmall bone fragments where screws are not indicated, and as adjunctsin external and intramedullary fixation systems involving plates androds, with fracture braces and casting.
	Specifically, the Arthrex Mini TightRope and the Mini TightRopeFT are intended to provide fixation during the healing processfollowing:
	1) Syndesmotic trauma, such as fixation of dorsal distal radioulnarligament (DRUL) disruptions;
	2) Tarsometatarsal (TMT) injury, such as fixation of foot soft tissueseparations due to a Lisfranc injury (Midfoot Reconstruction);and
	3) Hallux Valgus reconstruction (correction) by providing for thereduction of 1st metatarsal -2nd metatarsal intermetatarsal angle.
	The Arthrex Mini TightRope and the Mini TightRope FT, when usedfor fixation of bone-to-bone or soft-tissue-to-bone, are intended asfixation posts, distribution bridges, or for distributing suture tension
	over areas of ligament or tendon repair. Specifically, the ArthrexMini TightRope and the Mini TightRope FT are indicated for Carpal
	Metacarpal (CMC) joint arthroplasty as an adjunct in the healingprocess of the reconstruction of the ligament at the base of the thumbmetacarpal by providing stabilization between the base of the firstand second metacarpal when the trapezium has been excised due toosteoarthritis.
Substantial	The Mini TightRope with expanded indications is substantially
Equivalence	equivalent to the predicate Mini TightRope devices and the AC
Summary	RetroConstruction Button Kit in which the basic features areidentical and the intended uses are very similar. Any differencesbetween the Mini TightRope with expanded indications and thepredicate devices are considered minor and do not raise questionsconcerning safety and effectiveness. Based on the informationsubmitted, Arthrex, Inc. has determined that the Mini TightRope withexpanded indications is substantially equivalent to the currentlymarketed predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Arthrex, Inc. % Ms. Sally Foust Regulatory Affairs Project Manager 1370 Creekside Boulevard Naples, Florida 34108

AUG 0 6 2009

Re: K090107

Trade/Device Name: Mini TightRope Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HTN, HWC Dated: July 27, 2009 Received: July 29, 2009

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 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 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.

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Page 2 -- Ms. Sally Foust

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,
Mark M Millken

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

690107

K090107 510(k) Number (if known:

Mini TightRope Device Name:

Indications For Use:

Specifically, the Arthrex Mini TightRope and the Mini TightRope FT are intended to provide fixation during the healing process following:

1. Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament (DRUL) disruptions;
1. Tarsometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and
1. Hallux Valgus reconstruction (correction) by providing for the reduction of 185 metatarsal -2nd metatarsal intermetatarsal angle.

× Prescription Use (Per 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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 Surgical, Orthopedic, and Restorative Devices

K090107510(k) Number _

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
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.(b)
Classification. Class II.