The Knotless AC Repair Devices 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.
The Knotless AC Repair Devices are intended to provide fixation during the healing process following syndesmotic trauma, such as fixation of acromioclavicular separation due to coracoclavicular ligament disruption.
The Knotless AC Repair Devices with distal clavicle plate button are intended for use with Arthrex clavicle plates for clavicle indications and may not be used alone.

Device Description

The subject devices are suture constructs configured with one or two metal buttons made of titanium or stainless steel. The nonabsorbable suture is made of UHMWPE. Some of the subject devices are compatible with the Clavicle Fracture plates cleared under K112437.

AI/ML Overview

The provide FDA 510(k) summary describes the Arthrex Knotless AC Repair Devices, which are indicated as adjuncts in fracture repair and for fixation during syndesmotic trauma. The submission aims to demonstrate substantial equivalence to a predicate device, K052776: Arthrex TightRope Acromioclavicular (AC) Device, and refers to several other devices (K112437, K143139, K123341, K202581, K112990) as reference devices.

Here's an analysis of the acceptance criteria and study information provided:

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Demonstrated that modifications do not negatively impact mechanical strength compared to the predicate device. This implies specific thresholds for ultimate load and cyclic displacement.	Ultimate load testing and cyclic displacement were performed on the subject device and compared to the predicate device to demonstrate that the modifications do not negatively impact mechanical strength. (No specific numerical values or direct acceptance "pass/fail" stated, but the conclusion of non-negative impact implies acceptance.)
Device meets pyrogen limit specifications.	Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate that the device meets pyrogen limit specifications. (Implies meeting the standard, thus acceptance.)
Device is safe for use in an MR environment, specifically regarding: magnetic field induced displacement force, radiofrequency induced heating, and image artifact. (Based on standards: FDA guidance, ASTM F2052, ASTM F2119, ASTM F2182).	MRI force, torque, and image artifact testing were conducted in accordance with FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, ASTM F2052 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment, ASTM F2119 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants, and ASTM F2182 Standard Test Method for Measurement of Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging. (Implies that the testing demonstrated compliance with these standards, meaning the device met the safety criteria for MRI, thus acceptance.)
Overall, the device is substantially equivalent to the predicate, with differences being minor and not raising questions concerning safety and effectiveness.	"The Arthrex Knotless AC Repair Devices are substantially equivalent to the predicate in which the basic design features and intended use are the same. Any differences between the subject device and the predicate device are considered minor and do not raise questions concerning safety and effectiveness." (This is the overarching conclusion of the submission.)

Sample size for the test set and data provenance:
- The document mentions "ultimate load testing and cyclic displacement," "bacterial endotoxin" testing, and "MRI force, torque, and image artifact testing." However, it does not specify the sample sizes (e.g., number of devices tested) for any of these tests.
- Data provenance is not explicitly stated. These are laboratory tests, so the "country of origin of the data" would likely be the location of the testing facility, which is not provided. The tests are prospective in nature, as they are conducted specifically for this submission.
Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- This document describes mechanical, biocompatibility, and MRI compatibility testing of a medical device, not a diagnostic algorithm that requires expert-established ground truth. Therefore, this information is not applicable to this type of submission.
Adjudication method for the test set:
- Similar to point 3, this is not applicable as the studies are physical/chemical device tests, not involving human interpretation or clinical adjudication.
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:
- This is not applicable. The submission is for a physical medical device (suture button), not an AI-powered diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable. The device is a physical implant, not a software algorithm.
The type of ground truth used:
- For the mechanical tests, the "ground truth" would be the physical properties and performance characteristics of the predicate device, against which the subject device's mechanical performance is compared. Performance standards (e.g., ISO, ASTM) and established biological limits (e.g., pyrogen limits per EP/USP) serve as the "ground truth" or acceptance criteria for biocompatibility and MRI compatibility. Pathology or outcomes data are not relevant for this type of testing.
The sample size for the training set:
- This is not applicable. There is no "training set" as this is a physical device, not an AI/machine learning model.
How the ground truth for the training set was established:
- This is not applicable as there is no training set.

Summary

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June 6, 2022

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

Re: K220947

Trade/Device Name: Arthrex Knotless AC Repair Devices Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HTN Dated: March 30, 2022 Received: April 4, 2022

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.

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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 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 (QS) 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 medical devices and radiation-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.

Limin Sun, Ph.D. Acting Assistant Director DHT6A: Division of Joint Arthroplasty 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)

K220947

Device Name

Arthrex Knotless AC Repair Devices

Indications for Use (Describe)

The Knotless AC Repair Devices are intended to provide fixation during the healing process following syndesmotic trauma, such as fixation of acromioclavicular separation due to coracoclavicular ligament disruption.

The Knotless AC Repair Devices with distal clavicle plate button are intended for use with Arthrex clavicle plates for clavicle indications and may not be used alone.

Type of Use (Select one or both , as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Date Prepared	May 26, 2022
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
Contact Person	Ivette GalmezRegulatory Affairs Principal Specialist1-239-643-5553, ext. 71263Ivette.galmez@arthrex.com
Name of Device	Arthrex Knotless AC Repair Devices
Common Name	Suture Button
Product Code	HTN
Classification Name	21 CFR 888.3030: Single/multiple component metallic bone fixation appliances and accessories
Regulatory Class	II
Predicate Device	K052776: Arthrex TightRope Acromioclavicular (AC) Device
Reference Device	K112437: Arthrex Fracture SystemK143139: Arthrex Fracture System, SterileK123341: Arthrex Pec Repair ButtonK202581: Arthrex TightRope IIK112990: ACL TightRope
Purpose of Submission	This Traditional 510(k) premarket notification is submitted to obtain clearance for the ArthrexKnotless AC Repair Devices as a line extension to the Arthrex TightRope AC Device clearedunder K052776.
Device Description	The subject devices are suture constructs configured with one or two metal buttons made oftitanium or stainless steel. The nonabsorbable suture is made of UHMWPE. Some of thesubject devices are compatible with the Clavicle Fracture plates cleared under K112437.
Indications for Use	The Knotless AC Repair Devices are intended as adjuncts in fracture repair involvingmetaphyseal and periarticular small bone fragments where screws are not indicated, and asadjuncts in external and intramedullary fixation systems involving plates and rods, withfracture braces and casting.The Knotless AC Repair Devices are intended to provide fixation during the healing processfollowing syndesmotic trauma, such as fixation of acromioclavicular separation due tocoracoclavicular ligament disruption.The Knotless AC Repair Devices with distal clavicle plate button are intended for use withArthrex clavicle plates for clavicle indications and may not be used alone.
Summary ofTechnologicalCharacteristics	The proposed devices have similar technological characteristics as the predicate. The subjectdevices are configured with two buttons and are made of the same materials as thepredicate. Some models may include an attachable coracoid button. The subject devices aresold sterile for single use.
Performance Data	Ultimate load testing and cyclic displacement was performed on the subject device andcompared to the predicate device to demonstrate that the modifications do not negativelyimpact mechanical strength.Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate that the devicemeets pyrogen limit specifications.MRI force, torque, and image artifact testing were conducted in accordance with FDAguidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR)Environment, ASTM F2052 Standard Test Method for Measurement of Magnetically InducedDisplacement Force on Medical Devices in the Magnetic Resonance Environment, ASTMF2119 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants, andASTM F2182 Standard Test Method for Measurement of Measurement of Radio FrequencyInduced Heating Near Passive Implants During Magnetic Resonance Imaging.

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Conclusion	The Arthrex Knotless AC Repair Devices are substantially equivalent to the predicate in whichthe basic design features and intended use are the same. Any differences between thesubject device and the predicate device are considered minor and do not raise questionsconcerning safety and effectiveness.
	Based on the indications for use, technological characteristics, and the summary of datasubmitted, Arthrex Inc. has determined that the proposed device is substantially equivalentto the currently marketed predicate device.

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.