The Arthrex Fracture Plates are intended to be used for internal bone froctures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, fibula.

The Arthrex Low Profile Screws (2.0-2.4mm 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, and wrist. When used with a plate, the screw may be used with the Arthrex Low Profile, Small Fragment Plates, and Distal Extremity Plates.

The Arthrex Low Profile Screws (2.0-3.0mm cannulated) are intended to be used as stand-olone bone screws for internal bone fixation for bone froctures, fusions, ostectomies, and non-unions in the ankle, foot, hand, and wrist.

The Arthrex Low Profile Screws (2.5mm 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, alecranon, hymerus, radius, ulno, tibig, colconeous, femur, and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile, Smoll Fragment Plates, distal Extremity Plates, Humeral Fracture Plates, and Osteotomy Plates.

The Arthrex Low Profile Screws (3.5mm and larger, cannulated) are intended to be used as stand-alone bone screws for internal bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, clovicle, scapula, olecranon, humerus, radius, ulna, tibia, calconeous, femur, and fibula.

Device Description

The Arthrex Fracture Plates and Screws are a family of titanium and stainless steel plates and screws. The plates are flat and contoured, ranging from 50mm to 244mm in length. The accompanying screws are 2.0mm to 6.7mm in diameter.

AI/ML Overview

The provided document is a 510(k) premarket notification for Arthrex Fracture Plates and Screws. It describes a medical device, not a diagnostic AI/ML device. Therefore, the requested information regarding acceptance criteria and study data for an AI/ML device is not applicable to this document. The document focuses on demonstrating substantial equivalence to predicate devices for bone fixation plates and screws, including proposed sterilization methods and line extensions.

Summary

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JUL 0882014

Date Summary Prepared	July 8, 2014
Manufacturer/Distributor/Sponsor	Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA
510(k) Contact	David L.RogersRegulatory Affairs AssociateArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 71924Fax: 239/598.5508Email: david.rogers@Arthrex.com
Trade Name	Arthrex Fracture Plates and Screws
Common Name	Fastener, fixation, nondegradable soft tissue
Product Code -Classification Name	HRS - Plate, Fixation, BoneHWC - Screw, Fixation, Bone
CFR	21 CFR 888.3030: Single/multiple component metallicbone fixation appliances and accessories21 CFR 888.3040: Smooth or threaded metallic bonefixation fastener
Predicate Device	K123241: Arthrex Fracture PlatesK103705: Arthrex Low Profile Screws
Purpose of Submission	This special 510(k) premarket notification is submitted toobtain FDA clearance for the use of Gamma Irradiationand Ethylene Oxide sterilization for the Arthrex FracturePlates and Screws, which were cleared as non-steriledevices through K123241.This special 510(k) premarket notification is also intendedto address the addition of the Arthrex Distal FibulaPlates, the Arthrex Low Profile Screws (4.5, 5.5, & 6.0),the Arthrex 2.7 Low Profile Cortical Screws, and theArthrex 6.7 Low Profile Screws as line extensions toK123241, which are similar in design, and identical inmaterial and intended use.
Device Description	The Arthrex Fracture Plates and Screws are a family oftitanium and stainless steel plates and screws. The plates
	are flat and contoured, ranging from 50mm to 244mm inlength. The accompanying screws are 2.0mm to 6.7mmin diameter.
Intended Use	The Arthrex Fracture Plates and Screws are intended tobe used for internal bone fixation. See Indications forUse pages for specific indications.
Substantial Equivalence Summary	The Arthrex Fracture Plates and Screws are substantiallyequivalent to the predicate devices in which the basicdesign features and intended uses are the same. Anydifferences between the Arthrex Fracture Plates andScrews and the predicates are considered minor and donot raise questions concerning safety and effectiveness.
	The predicate devices are cleared as non-sterile devices.The proposed plates will undergo Gamma Irradiation orEthylene Oxide (EO) sterilization.
	The engineering analysis conducted on the distal fibulaplates demonstrates that there is no significant differencein bending strength between the Arthrex Distal FibulaPlates and the predicate.
	The screw torsion and pullout testing conducted on theadditional screws demonstrates that the torsionalproperties and pullout strength are higher or equivalentto the predicate.
	Based on the indications for use, technologicalcharacteristics, and the summary of data submitted,Arthrex, Inc. has determined that the Arthrex FracturePlates and Screws are substantially equivalent to thepredicates.

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. . . . .

and the state of the state of the states and

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three curved lines representing its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G605 Silver Spring, MI) 20993-0002

July 8, 2014

Arthrex, Inc. Mr. David L. Rogers Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108

Re: K141478

Trade/Device Name: Arthrex Fracture Plates and Screws 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: June 12, 2014 Received: June 13. 2014

Dear Mr. Rogers:

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

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Page 2 - Mr. David L. Rogers

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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 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 yours,

Lori A. Wiggins

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

Enclosure

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2.5 INDICATIONS FOR-USE

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-01 Expiration Date: December 31, 201 See PRA Statement on last page.

510(k) Number (if known)

K141478

Device Name

Arthrex Fracture Plates and Screws

Indications for Use (Describe)

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

0 Prescription Use {Part 21 CFR 801 Subpart D}

0 Over-The-Counter Use {21 CFR 801 Subpart C}

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)

Elizabeth @Frank -S

Division of Orthopedic Devices

FORM FDA 3881 (9/13)

Mr. In ato 2 com Second . Join and

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.