The Tenodesis Button is used for fixation of bone or soft tissue to bone, and is intended as fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair in the knee, shoulder, and elbow and may include the following indications; anterior cruciate ligament, posterior cruciate ligament, pectoralis repair (minor/major), biceps tendon repair and reattachment (distal/proximal), acromioclavicular repair, and ulnar collateral ligament reconstruction.

Device Description

The Arthrex Tenodesis Button is made of titanium alloy. The proposed button is preloaded onto a driver/inserter, for single use. The holes in the button allow for the buttons to be threaded with Arthrex non-absorbable suture.

AI/ML Overview

This document is an FDA 510(k) clearance letter for a medical device called the "Arthrex Tenodesis Button." This type of document does not describe an AI/ML powered device, nor does it contain information about an AI/ML study, acceptance criteria, or ground truth establishment in the way AI/ML product submissions do.

Therefore, I cannot provide the requested information, which pertains to the acceptance criteria and study proving an AI/ML device meets those criteria. The provided text describes a physical medical implant and its clearance based on substantial equivalence to a predicate device, supported by physical performance testing (tensile, cyclic loading, MR compatibility, bacterial endotoxin testing), not an AI/ML model's performance on a test set.

The categories you've asked for (such as experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are specific to the validation of AI/ML diagnostic or prognostic tools and are not applicable to the clearance of this type of traditional medical device.

Summary

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Arthrex Inc. Ivette Galmez Senior Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K190288

Trade/Device Name: Arthrex Tenodesis Button Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: August 9, 2019 Received: August 12, 2019

Dear Ivette Galmez:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 warranties. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Laurence D. Coyne, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K190288

Device Name

Arthrex Tenodesis Button

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
× Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

K190288

Date Prepared	March 26, 2019
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
Contact Person	Ivette GalmezSenior Regulatory Affairs Specialist1-239-643-5553, ext. 71263Ivette.galmez@arthrex.com
Name of Device	Arthrex Tenodesis Button
Common Name	Fastener, fixation, nondegradable, soft tissue
Product Code	MBI
Classification Name	21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener
Regulatory Class	II
Predicate Device	K123341: Arthrex Pec Repair Button, Large Pec Button, Biceps Button and ProximalBiceps Button
Purpose of Submission	This traditional 510(k) premarket notification is submitted to obtain clearance for theArthrex Tenodesis Button. This submission contains a modification to the devicelabeling to include the "MR Conditional" statement in accordance with the FDAGuidance, "Establishing Safety and Compatibility of Passive Implants in the MagneticResonance (MR) Environment".
Device Description	The Arthrex Tenodesis Button is made of titanium alloy. The proposed button ispreloaded onto a driver/inserter, for single use. The holes in the button allow for thebuttons to be threaded with Arthrex non-absorbable suture.
Indications for Use	The Arthrex Tenodesis Button is used for fixation of bone to bone or soft tissue tobone, and is intended as fixation post, a distribution bridge, or for distributing suturetension over areas of ligament or tendon repair in the knee, shoulder, and elbow andmay include the following indications; anterior cruciate ligament, posterior cruciateligament, pectoralis repair (minor/major), biceps tendon repair and reattachment(distal/proximal), acromioclavicular repair, and ulnar collateral ligamentreconstruction.
Performance Data	Tensile testing and cyclic loading was conducted to demonstrate that the proposedbutton performs similar to the predicate device.Non-clinical testing per the FDA Guidance, "Establishing Safety and Compatibility ofPassive Implants in the Magnetic Resonance (MR) Environment", demonstrated thatthe Arthrex buttons are "MR Conditional".Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate that thedevice meets pyrogen limit specifications.
Conclusion	The Arthrex Tenodesis Button is substantially equivalent to the predicate device inwhich the basic design features and intended uses are the same. Any differencesbetween the proposed device and the predicate device are considered minor and donot raise questions concerning safety or effectiveness.Based on the indications for use, technological characteristics, and the summary ofdata submitted, Arthrex Inc. has determined that the proposed devices aresubstantially equivalent to the currently marketed predicate device.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.