The Arthrex RetroButton™ for fixation of bone to bone or soft tissue to bone, and is intended as a fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering this for Anterior Cruciate Ligament (ACL) Repair.

Device Description

The Arthrex RetroButton™ is a pre-threaded button construct.

AI/ML Overview

The provided text is a 510(k) summary for the Arthrex RetroButton™, a medical device used for fixation of bone to bone or soft tissue to bone, specifically for Anterior Cruciate Ligament (ACL) Repair.

The document does not contain any information regarding acceptance criteria or a study proving that the device meets such criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Arthrex FiberWire® Button Repair Kit K031666).

Therefore, I cannot provide the requested information. The concepts of "acceptance criteria," "reported device performance," "sample size for test set," "data provenance," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," "sample size for training set," and "ground truth establishment for training set" are typically associated with performance studies conducted for medical devices, often when a new technology is introduced or significant changes are made.

In this 510(k) submission, the primary method of demonstrating safety and effectiveness is through substantial equivalence to an already legally marketed device. This means the manufacturer argues that the new device is as safe and effective as the predicate device because it shares similar technological characteristics and intended uses, without necessarily requiring new clinical performance data or studies against specific acceptance criteria.

Summary

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K062747 pg 1 of 1

VIII. 510(k) Summary of Safety and Effectiveness

Arthrex RetroButton™

Manufacturer / Sponsor	Arthrex, Inc.1370 Creekside BoulevardNaples, Florida 34108-1945			SEP 29 2000
510(k) Contact:	Ann Waterhouse, RACRegulatory Affairs Project ManagerTelephone: (239) 643-5553 ext. 1179FAX: (239) 598-5508
Trade Name:	Arthrex RetroButton™
Common Name:	Plate, fixation, boneSuture, synthetic, nonabsorbable, polyethyleneor silk
Product Code /Classification Name:	HRS, 21 CFR 888.3030Plate, Fixation, bone
	GAT, 21 CFR 878.5000Suture, synthetic, nonabsorbable, polyethylene
	GAP, 21 CFG 878.5030Suture, nonabsorbable, silk
Predicate Device:	Arthrex FiberWire® Button Repair Kit K031666

Device Description and Intended Use:

The Arthrex RetroButton™ is a pre-threaded button construct.

The Arthrex RetroButton™ for fixation of bone to bone or soft tissue to bone, and is intended as a fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrey will he offering this for Anterior Cruciate Ligament (ACL) Repair.

Substantial Equivalence:

The Arthrex RetroButton™ is substantially equivalent to the predicate Arthrex FiberWire® Button Repair Kit in which the basic features and intended uses are the same. Any differences between the Arthrex RetroButton™ and the prodicate are considered minor and do not raise questions concerning safety and effectiveness. Based on the information submitted, Arthrex, Inc. has deterrined that the RetroButton™ is substantially equivalent to the currently marketed predicate device.

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

od and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Arthrex, Inc. % Ms. Ann Waterhouse, RAC Regulatory Affairs Project Manager 1370 Creekside Boulevard Naples, Florida 34108-1945

SEP 29 2006

Re: K062747

============================================================================================================================================================================== Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, GAT, GAP Dated: September 13, 2006 Received: September 14, 2006

Dear Ms. Waterhouse:

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.

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Page 2 - Ms. Ann Waterhouse, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) rmarket 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" (21CFR 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,

Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Form ll.

510(k) Number (if known):

510(k) Number (if known): 《062747

Device Name: Arthrex RetroButton™

Indications for Use:

Prescription Use_ × (Per 21 CFR 801 Subpart D) AND/OR 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)

Page 1 of 1 -

(Division b Division of General, Restorative, and Neurological Devices

510(k) Number IL062797

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.