The Arthrex Mesh Plate is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bone fragments of the hand/wrist, foot/ankle, and osteopenic bone.

The Arthrex Low Profile Screws (3.0 mm, solid) are intended to be used as stand-alone bone screws, or in a plate screw system for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, and wrist. When used with a plate, the screw may be used with the Arthrex Mesh Plates.

Device Description

The Arthrex Mesh Plate System is a family of plates and screws made from stainless steel and titanium. The system is comprised of the Arthrex Mesh Plates and accompanying Arthrex Low Profile Screws. The proposed plates in long and short versions are offered sterile and non-sterile.

The accompanying screws are 3.0 mm low profile screws with lengths ranging from 42 mm to 50 mm. The proposed screws are offered sterile and non-sterile.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Arthrex Mesh Plate System, which is a metallic bone fixation appliance and accessories. This type of regulatory submission demonstrates substantial equivalence to legally marketed predicate devices, rather than proving device safety and effectiveness through clinical studies with acceptance criteria as one would find for novel devices or software with AI/ML components.

Therefore, the document does not contain the information requested regarding acceptance criteria related to a study proving performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or ground truth for training sets.

Instead, the submission relies on:

Mechanical testing performed in accordance with ASTM F 382-14 (Standard Specification and Test Method for Metallic Bone Plates).
Bacterial endotoxin testing in accordance with USP <85>.
Demonstration of substantial equivalence to predicate devices (K111253: Arthrex Distal Extremity Plate System, K143614: Arthrex Low Profile Screws, and K150456: Arthrex Plates, Screws, and Staples) based on intended use, technological characteristics, and mechanical testing data for bending strength, fatigue testing of plates, and torque and pull-out testing of screws.

The document explicitly states: "Any differences between the Arthrex Mesh Plate System and the predicates are considered minor and do not raise questions concerning safety and effectiveness." This indicates that the regulatory pathway is based on demonstrating similarity to existing, approved devices, not on de novo clinical performance studies with specific statistical acceptance criteria that would typically be associated with AI/ML devices.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them, resembling a symbol or emblem.

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

September 1, 2017

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

Re: K170547

Trade/Device Name: Arthrex Mesh Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: July 25, 2017 Received: July 28, 2017

Dear Ms. 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. 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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

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 Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Mark N. Melkerson -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K170547

Device Name

Arthrex Mesh Plate System

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K170547

Device Name

Arthrex Mesh Plate System

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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2.1 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Date Summary Prepared	August 30, 2017
Manufacturer/Distributor/Sponsor	Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA
510(k) Contact	Ivette GalmezSenior Regulatory Affairs SpecialistArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 71263Fax: 239/598.5508Email: igalmez@arthrex.com
Trade Name	Arthrex Mesh Plate System
Common Name	Plate, fixation, bone
Product Code -	HRS, HWC
Classification NameCFR	21 CFR 888.3030: Single/multiple component metallic bone fixation appliances andaccessories, 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener
Predicate Device	K111253: Arthrex Distal Extremity Plate SystemK143614: Arthrex Low Profile Screws
Reference Predicate	K150456: Arthrex Plates, Screws, and Staples
Purpose of Submission	This 510(k) premarket notification is submitted to obtainclearance for the Arthrex Mesh Plate System, a line extension tothe Arthrex Distal Extremity Plate System in K111253 andK150456.
Device Description	The Arthrex Mesh Plate System is a family of plates and screwsmade from stainless steel and titanium. The system iscomprised of the Arthrex Mesh Plates and accompanyingArthrex Low Profile Screws. The proposed plates in long andshort versions are offered sterile and non-sterile.The accompanying screws are 3.0 mm low profile screws withlengths ranging from 42 mm to 50 mm. The proposed screwsare offered sterile and non-sterile.
Intended Use	The Arthrex Mesh Plate is intended for use in stabilization offresh fractures, revision procedures, osteotomies, joint fusionand reconstruction of small bones and bone fragments of thehand/wrist, foot/ankle, and osteopenic bone.The Arthrex Low Profile Screws (3.0 mm, solid) are intended tobe used as stand-alone bone screws, or in a plate screw systemfor internal bone fixation for bone fractures, fusions,osteotomies, and non-unions in the ankle, foot, hand, and wrist.When used with a plate, the screw may be used with the ArthrexMesh Plates.
Substantial EquivalenceSummary	The Arthrex Mesh Plate System is substantially equivalent to thepredicate devices, in which the scientific technology, andintended uses are the same. Any differences between theArthrex Mesh Plate System and the predicates are consideredminor and do not raise questions concerning safety andeffectiveness.Bacterial endotoxin testing was performed in accordance toUSP <85>.Mechanical testing data was performed in accordance to ASTMF 382-14 (Standard Specification and Test Method for MetallicBone Plates).The submitted data for the proposed Arthrex Mesh PlateSystem demonstrates that the bending strength and fatiguetesting of the plates, and the torque and pull out testing of theaccompanying screws are substantially equivalent to that of thepredicate devices for the desired indications.Based on the intended use, technological characteristics and thesummary of data submitted, Arthrex, Inc. has determined thatthe Arthrex Mesh Plate System is substantially equivalent to thepredicate.

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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.