The Arthrex DynaNite Nitinol Staple is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.

Device Description

The Arthrex DynaNite Nitinol Staple is a Nickel Titanium (Nitinol) bone fixation device intended to be permanently implanted. The implant is formed with two legs connected by a bridge and is offered in multiple combinations of bridge widths, leg lengths, and cross sections to accommodate various anatomies.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Arthrex DynaNite Nitinol Staple." This document focuses on demonstrating substantial equivalence to predicate devices, rather than proving a new device's absolute performance against specific acceptance criteria for a novel AI/software function.

Therefore, the information required to answer the prompt regarding AI/software device acceptance criteria and a study proving those criteria is not present in the provided text. The document pertains to a traditional medical device (a bone fixation staple), and the "Performance Data" section discusses mechanical properties, corrosion, and biocompatibility, not AI performance.

Hence, I cannot populate the requested tables and information.

Summary

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December 13, 2017

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Arthrex Inc. Rebecca R. Homan Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K172052

Trade/Device Name: Arthrex DynaNite Nitinol Staple Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: JDR Dated: October 18, 2017 Received: October 20, 2017

Dear Ms. Homan:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Katherine D. Kavlock -S

for

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

Enclosure

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Indications for Use

510(k) Number (if known)

K172052

Device Name Arthrex DynaNite Nitinol Staple

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	June 30, 2017
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
Contact Person	Rebecca R. HomanRegulatory Affairs Associate1-239-643-5553, ext. 73429rebecca.homan@arthrex.com
Name of Device	Arthrex DynaNite Nitinol Staple
Common Name	Staple
Product Code	JDR
Classification Name	21 CFR 888.3030: Single/multiple component metallic bone fixation appliancesand accessories
Regulatory Class	II
Predicate Device	K043059: Wright Medical Technology Compression staple and simple stapleK153129: MX Orthopedics dynaMX Tabbed StapleK993714: BioMedical Enterprises, Inc. Memograph Staple
Purpose ofSubmission	This Traditional 510(k) premarket notification is submitted to obtain clearance forthe Arthrex DynaNite Nitinol Staple.
Device Description	The Arthrex DynaNite Nitinol Staple is a Nickel Titanium (Nitinol) bone fixationdevice intended to be permanently implanted. The implant is formed with twolegs connected by a bridge and is offered in multiple combinations of bridgewidths, leg lengths, and cross sections to accommodate various anatomies.
Indications for Use	The Arthrex DynaNite Nitinol Staple is intended to be used for fixation such as:LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, firstmetatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfootarthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment(Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint toreposition and stabilize metatarsus primus varus.
Performance Data	To demonstrate product performance, Arthrex has conducted static four-pointbending strength, pull-out strength, and fatigue resistance and compared theresults to the predicate device. Corrosion and transformation temperaturetesting were also conducted.Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate thatthe device meets pyrogen limit specifications.
Conclusion	The Arthrex DynaNite Nitinol Staple is substantially equivalent to the predicatedevice in which the basic design features and intended uses are the same. Anydifferences between the proposed device and the predicate device areconsidered minor and do not raise questions concerning safety or effectiveness.Based on the indications for use, technological characteristics, and the summaryof data submitted, Arthrex Inc. has determined that the proposed device issubstantially equivalent to 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.