The Arthrex Pec Repair Button, Large Pec Button, Biceps Button, and Proximal Biceps Button are 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 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 four proposed Arthrex suture buttons are titanium oblong buttons that consist of two eyelets each that allow the buttons to be threaded with a variety of suture options. The Arthrex Pec Button, Large Pec Button, Biceps Repair Button and Proximal Biceps Buttons are 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 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.

AI/ML Overview

The provided text describes a 510(k) submission for several Arthrex suture buttons, focusing on demonstrating substantial equivalence to predicate devices through mechanical testing. The information required for a comprehensive AI device study report (e.g., training set details, expert ground truth adjudication) is not applicable or not present in this document, as the device is a physical medical implant, not an AI or software-based device.

Therefore, the following information is extracted or stated as not applicable based on the provided input:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Mechanical Tensile Strength	Met or exceeded acceptance criteria for proposed indications and the ultimate load to failure seen clinically for pectoralis repair.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size: Not specified (mechanical testing, not a clinical data set).
Data Provenance: Not applicable by country or retrospective/prospective as this describes mechanical testing in a lab setting, not human subject data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. Ground truth for a physical device's mechanical performance is typically based on established engineering standards and material science, not retrospective expert consensus on medical images or diagnoses.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This is for mechanical testing, not clinical diagnosis consensus.

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 device is a physical implant, not an AI or software device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical implant, not an AI or software device. The study describes standalone mechanical performance of the device, but not in the context of an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Ground truth was based on established biomechanical and engineering standards for tensile strength and ultimate load to failure for soft tissue fixation, as well as clinical expectations for pectoralis repair.

8. The sample size for the training set

Not applicable. This device is a physical implant, not an AI or software device. The concept of a "training set" is not relevant here.

9. How the ground truth for the training set was established

Not applicable. See above.

Summary

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DEC 2 1 2012

510(k) Summary of Safety and Effectiveness

Date Summary Prepared	October 26, 2012
Manufacturer/Distributor/Sponsor	Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA
510(k) Contact	Christina FloresRegulatory Affairs SpecialistArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 1819Fax: 239/598.5508Email: Christina.flores@arthrex.com
Trade Name	Arthrex Pec Repair ButtonArthrex Large Pec ButtonArthrex Biceps ButtonArthrex Proximal Biceps Button
Common Name	fastener, fixation, nondegradable, soft tissue
Product Code -ClassificationNameCFR	21 CFR 888.3040: Smooth or threaded metallic bonefixation fastenerMBI - fastener, fixation, nondegradable, soft tissue
Predicate Device	K031666 - Arthrex FiberWire® Button Repair KitK062747 - Arthrex RetroButtonK083070 - Biomet ToggleLoc® System
Purpose of Submission	This Traditional 510(k) premarket notification issubmitted to obtain clearance for the Arthrex Pec RepairButton, Large Pec Button, Biceps Button and ProximalBiceps Button to expand the Arthrex Suture Buttonproduct offering. No prior submissions have beensubmitted for the subject devices.
Device Description and IntendedUse	The four proposed Arthrex suture buttons are titaniumoblong buttons that consist of two eyelets each that allowthe buttons to be threaded with a variety of suture options.The Arthrex Pec Button, Large Pec Button, BicepsRepair Button and Proximal Biceps Buttons are used forfixation of bone to bone or soft tissue to bone, and areintended as fixation posts, a distribution bridge, or fordistributing suture tension over areas of ligament or tendonrepair in the knee, shoulder, and elbow and may includethe following indications; anterior cruciate ligament,posterior cruciate ligament, pectoralis repair(minor/major), biceps tendon repair and reattachment
	(distal/proximal), acromioclavicular repair, and ulnarcollateral ligament reconstruction.
Substantial EquivalenceSummary	The proposed Arthrex Pec Button, Large Pec Button,Biceps Repair Button and Proximal Biceps Button aresubstantially equivalent to the predicate devices, in whichthe basic features and intended uses are the same. Corticalbutton fixation using a variety of button configurations andsuture combinations has been shown to be abiomechanically strong method of treating various tendonand ligament injuries. The addition of Pectoralis repair(minor/major) to the indications of the proposed devices donot raise new questions of safety or effectiveness as thefixation properties of the proposed devices meet or exceedthe ultimate load to failure seen clinically for this type ofrepair. Any other differences between the Arthrexproposed devices and the predicates are considered minorand do not raise questions concerning safety andeffectiveness..Results of mechanical testing which included tensilestrength, demonstrated that the proposed products met theacceptance criteria for the proposed indications.

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. .

Comments of the comments of

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the HHS logo, which is a stylized human figure embracing the world. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the logo.

Public Health Service

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

December 21, 2012

Arthrex, Incorporated % Ms. Christina Flores Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108

Re: K123341

Trade/Device Name: Arthrex Pec Repair Button, Large Pec Button, Biceps Button and Proximal Biceps Button

Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: October 26, 2012 Received: October 31, 2012

Dear Ms. Flores:

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. 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 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

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Page 2 - Ms. Christina Flores

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.

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/CDRH0ffices/ucm115809.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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Peter D. Rumm -S

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

Enclosure

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1 Indications for Use Form

Indications for Use

K123341 510(k) Number:

Device Name: Arthrex Pec Repair Button, Large Pec Button, Biceps Button, and Proximal Biceps Button

Indications for Use:

Prescription Use _ X_AND/OR Over-The-Counter Use _ (Per 21 CFR 801 Subpart D) (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)

Casey Hanley

For Division of Orthopaedic Devices

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.