The Arthrex Tightrope Soft Button, RT implant is intended to be used for fixation of bone or soft tissue to bone, and are intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering these for ACLI PCL repair and reconstruction MCL, POL, LCL repair and reconstruction; ITB and PTR repair; and MPFL, ALL, quadriceps tendon, PLC repair and reconstruction for the adult patient population.

Device Description

The proposed Arthrex TightRope Soft Button, RT is comprised of a suture loop, suture button and passing sutures. The suture loop and passing sutures are braided nonabsorbable surgical sutures.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "Arthrex TightRope Soft Button, RT". This type of document is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.

The summary does not contain information about acceptance criteria or a detailed study report with the specific metrics requested. Instead, it states that the device is "equivalent to the primary Arthrex ACL Tightrope RC predicate device" based on "cyclic pull-out testing".

Therefore, I cannot provide the detailed tables and information requested, as it is not present in the provided text.

Based on the information available:

1. Table of acceptance criteria and reported device performance:
This information is not explicitly provided in the document. The document states: "Based on cyclic pull-out testing, the proposed Arthrex TightRope Soft Button, RT device is equivalent to the primary Arthrex ACL Tightrope RC predicate device." This implies that the performance of the new device met the performance of the predicate device in cyclic pull-out testing, but the specific acceptance criteria and the numerical results are not given.

2. Sample size used for the test set and the data provenance:
Not specified in the document. The document only mentions "cyclic pull-out testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable as this is a mechanical test, not an evaluation by human experts using a test set with ground truth.

4. Adjudication method for the test set:
Not applicable for a mechanical test.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a medical device for bone/soft tissue fixation, not an AI-powered diagnostic tool requiring MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a medical device, not an algorithm. The "equivalence" is based on mechanical performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" here would be the validated performance of the predicate device in cyclic pull-out testing, which serves as the benchmark for equivalence. The specific details of that ground truth are not provided.

8. The sample size for the training set:
Not applicable. This is a mechanical device, not an AI or machine learning model that requires a training set.

9. How the ground truth for the training set was established:
Not applicable.

Summary of available details regarding the study:

Study type: Cyclic pull-out testing (a type of mechanical bench testing).
Purpose: To demonstrate substantial equivalence to a predicate device (Arthrex ACL TightRope RC, K112990).
Outcome: The proposed device was found to be "equivalent" to the predicate.

Summary

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March 11, 2025

Arthrex Inc. Erikka Edwardsen Team Lead Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108

Re: K250424

Trade/Device Name: Arthrex TightRope Soft Button, RT Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: February 13, 2025 Received: February 14, 2025

Dear Erikka Edwardsen:

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/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,

CHRISTOPHER FERREIRA -S

Christopher Ferriera, MS 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

Submission Number (if known)

K250424

Device Name

Arthrex TightRope Soft Button, RT

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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Image /page/4/Picture/0 description: The image shows the logo for Arthrex. The logo consists of the word "Arthrex" in a bold, sans-serif font. To the right of the word is an image of a surgical instrument, resembling a pair of scissors with a specialized attachment. The logo is simple and modern, and the surgical instrument suggests that the company is involved in the medical field.

510(k) Summary

Date Prepared	March 11, 2025
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
Contact Person	Name: Erikka EdwardsenTitle: Team Lead Regulatory AffairsPhone: 1-239-343-5553, ext. 70422Email: rikka.edwardsen@arthrex.com
Trade Name	Arthrex TightRope Soft Button, RT
Common Name	Smooth or threaded metallic bone fixation fastener
Product Code	MBI - Fastener, Fixation, Nondegradable, Soft Tissue
Classification Name	21 CFR 888.3040: Smooth or threaded metallic bone fastener
Regulatory Class	II
Primary Predicate	K112990 – Arthrex ACL TightRope RC
Additional Predicate	K241235 - Arthrex TightRope II RT
Reference Devices	K230976 – Arthrex Radiopaque FiberTape Cerclage sutures
Purpose of Submission	This Special 510(k) premarket notification is submitted to obtain clearance for the Arthrex TightRope Soft Button, RT as a line extension to previously cleared TightRope devices (K112990, K241235).
Device Description	The proposed Arthrex TightRope Soft Button, RT is comprised of a suture loop, suture button and passing sutures. The suture loop and passing sutures are braided nonabsorbable surgical sutures.
Indications for Use	The Arthrex Tightrope Soft Button, RT implant is intended to be used for fixation of bone to bone or soft tissue to bone, and are intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering these for ACL/PCL repair and reconstruction MCL, POL, LCL repair and reconstruction; ITB and PTR repair; and MPFL, ALL, quadriceps tendon, PLC repair and reconstruction for the adult patient population.

Performance Data	Based on cyclic pull-out testing, the proposed ArthrexTightRope Soft Button, RT device is equivalent to theprimary Arthrex ACL Tightrope RC predicate device.
Technological Comparison	The proposed Arthrex TightRope Soft Button, RT devicehas similar technological characteristics as the primarypredicate and reference devices. The suture used in theproposed Arthrex TightRope Soft Button, RT device isidentical to legally marketed Arthrex primary predicateand reference devices. The primary difference betweenthe subject, primary predicate and reference devices isthat the proposed Arthrex TightRope Soft Button, RT ismanufactured with an all-suture radiopaque buttonrather than a titanium button.
Conclusion	Therefore, based on the intended use, fundamentalscientific technology, and the data provided in thisSpecial 510(k), Arthrex has determined that theproposed Arthrex TightRope Soft Button, RT device inthis submission is substantially equivalent to theprimary predicate and reference devices. Anydifferences between the proposed device and theprimary predicate and reference devices are consideredminor and do not raise any new or different questionsconcerning safety and effectiveness.

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Image /page/5/Picture/0 description: The image shows the Arthrex logo. The logo consists of the word "Arthrex" in a sans-serif font, followed by a registered trademark symbol. To the right of the word is an image of a surgical tool, resembling a pair of scissors with a specialized attachment.

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.