Arthrex Low Profile Screws by Arthrex Inc.

The Arthrex Low Profile Screws (3.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur, and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile, Small Fragment Plates, Distal Extremity Plates, Humeral Fracture Plates, and Osteotomy Plates.

Device Description

The Arthrex Low Profile Screws are a family of screws that are offered in a 3.5 mm diameter, length range of 85 to 120 mm, in a solid and fully threaded design. The Arthrex Low Profile Screws are manufactured from Stainless Steel materials conforming to ASTM F138. The screws are sold sterile or non-sterile and single-use.

AI/ML Overview

This document is a 510(k) summary for the Arthrex Low Profile Screws. It describes mechanical testing performed to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating device performance against pre-defined acceptance criteria for a diagnostic algorithm. Therefore, many of the requested fields are not applicable.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Mechanical integrity and performance statistically equivalent to predicate devices for insertion torque/failure torque	Insertion torque/failure torque demonstrated to be statistically equivalent to the predicate.
Design modifications to previously cleared 3.5 mm Arthrex Low Profile Screws do not affect safety or performance (evaluated via pull-out testing and insertion torque/failure torque testing)	Pull-out testing and insertion torque/failure torque testing conducted on previously cleared 3.5 mm screws demonstrated that design modifications do not affect safety or performance.
MR compatibility per ASTM F2052-15 (displacement force), ASTM F2213-17 (torque), ASTM F2119-13 (image artifact)	MR compatibility testing successfully conducted per specified ASTM standards.

2. Sample sized used for the test set and the data provenance:

Sample size: Not specified. The document mentions "mechanical testing data" but does not quantify the number of screws or tests performed.
Data provenance: Not explicitly stated, however, as mechanical testing, it would be laboratory-generated data, not from human subjects or clinical settings, thus neither retrospective nor prospective in the typical sense for clinical data. It would be considered prospective for the testing itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This document describes mechanical testing of a physical device, not the evaluation of a diagnostic tool against a ground truth established by experts.

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

Not Applicable. Adjudication methods are relevant for clinical studies involving reader interpretations, not for mechanical testing.

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 510(k) for a medical screw, not an AI or diagnostic imaging device.

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

Not Applicable. This document is for a physical medical device, not an algorithm.

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

Not Applicable. For mechanical testing, the "ground truth" would be the measured physical properties and performance metrics of the previous devices as a benchmark for comparison.

8. The sample size for the training set:

Not Applicable. This document describes mechanical testing, not a machine learning model or algorithm that requires a training set.

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

Not Applicable. See point 8.

Summary

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December 30, 2020

Samantha Passman Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K203239

Trade/Device Name: Arthrex Low Profile Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, HRS Dated: October 30, 2020 Received: November 3, 2020

Dear Samantha Passman:

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

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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,

Shumaya Ali, M.P.H. 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) K203239

Device Name Arthrex Low Profile Screws

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

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	December 30, 2020
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
Contact Person	Samantha PassmanRegulatory Affairs Associate1-239-643-5553, ext. 71595Samantha.passman@arthrex.com
Name of Device	Arthrex Low Profile Screws
Common Name	Screw, fixation, bone
Product Code	HWC, HRS
Classification Name	21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener (primary)21 CFR 888.3030: Single/multiple component metallic bone fixation appliancesand accessories
Regulatory Class	II
Predicate Device	K103705: Arthrex Low Profile Screws (Reference)K112437: Arthrex Fracture SystemK141487: Arthrex Fracture Plates and Screws (Primary)K143139: Arthrex Fracture SystemK143614: Arthrex Low Profile Screws
Purpose of Submission	This Traditional 510(k) premarket notification is submitted to obtain clearance forthe Arthrex Low Profile Screws as a line extension to the Arthrex Low ProfileScrew family of products. This submission is also intended to document themodifications made and to the previously cleared 3.5 mm Arthrex Low ProfileScrews cleared under K103705, K112437, K143139 and K143614.
Device Description	The Arthrex Low Profile Screws are a family of screws that are offered in a 3.5mm diameter, length range of 85 to 120 mm, in a solid and fully threaded design.The Arthrex Low Profile Screws are manufactured from Stainless Steel materialsconforming to ASTM F138. The screws are sold sterile or non-sterile and single-use.
Indications for Use	The Arthrex Low Profile Screws (3.5mm and larger, solid) are intended to beused as standalone bone screws, or in a plate-screw system for internal bonefixation for bone fractures, fusions, osteotomies and non-unions in the ankle,foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia,calcaneous, femur and fibula. When used with a plate, the screws may be usedwith the Arthrex Low Profile, Small Fragment Plates, Fracture Plates, DistalExtremity Plates, Humeral Fracture Plates, and Osteotomy Plates.
Performance Data	Insertion torque/failure torque was conducted to demonstrate that the proposedscrews perform statistically equivalent to the predicate.Pull-out testing and insertion torque/failure torque testing was conducted on thepreviously cleared 3.5 mm Arthrex Low Profile Screws to demonstrate that thedesign modifications do not affect the safety or performance.MR compatibility testing was also conducted per ASTM F2052-15 (displacementforce), ASTM F2213-17 (torque), ASTM F2119-13 (image artifact), and ASTM
Conclusion	The proposed Arthrex Low Profile Screws are substantially equivalent to the predicate devices in which the basic design features and intended uses are the same. Any differences between the proposed devices and the predicate devices are considered minor and do not raise different questions concerning safety or effectiveness.
	The submitted mechanical testing data demonstrates that the push-out and torque strength of the proposed devices are substantially equivalent to that of the predicate devices for the desired indications.
	Based on the indications for use, technological characteristics, and the summary of data submitted, Arthrex Inc. has determined that the proposed devices are substantially equivalent to the currently marketed predicate device.

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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.