The Akros FibuLink™ Syndesmosis Repair Kit is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated and as an adjunct to fixation systems involving plates, with fracture braces and casting. Specifically, the Akros FibuLink™ Syndesmosis Repair Kit is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures.

Device Description

The Akros FibuLink™ Syndesmosis Repair Kit is a multiple-anchor orthopedic fixation device system, offered in both a stainless steel and a titanium version. The system is designed as an adjunct in repair of unstable joints, specifically as a means to provide fixation between the tibia and fibula during the healing process following a disruption of the ankle syndesmosis. If a fracture of the fibula is present, the design of the fibula anchor permits placement through any fibula fracture repair plate that can accept a 3.5mm cortical screw conforming to ASTM F543-13. The anchors are provided pre-threaded and pre-loaded on their installation tools in a one-time-use pre-sterilized kit, with the Kirschner wire and drill bit needed for site preparation included.

The current submission is for minor design modifications to the components that make up the tibia and fibula anchors and corresponding changes to some of the tools used to install them.

AI/ML Overview

This document is a 510(k) premarket notification for the Akros FibuLink™ Syndesmosis Repair Kit. It describes the device, its intended use, and a summary of non-clinical testing conducted. However, it explicitly states that clinical testing was not necessary to demonstrate substantial equivalence to the predicate device.

Therefore, the requested information regarding acceptance criteria, a study proving the device meets these criteria, sample sizes, ground truth establishment, expert involvement, or multi-reader multi-case studies cannot be provided from the given text.

The information that can be extracted relates to the non-clinical testing performed to establish equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed numerical results for each test. Instead, it offers a qualitative statement about the outcomes.

Test Type	Acceptance Criteria (Implied)	Reported Device Performance
Lateral pull-to-failure	Adequate strength for intended use; comparable to predicate device	"The results of these tests indicate that the performance of the FibuLink™ device is adequate for its intended use."
Offset load-to-failure	Adequate strength for intended use; comparable to predicate device	"The results of these tests indicate that the performance of the FibuLink™ device is adequate for its intended use."
Insertion torque	Appropriate torque for bone insertion	"The results of these tests indicate that the performance of the FibuLink™ device is adequate for its intended use."
Torque-to-failure	Adequate resistance to failure; comparable to predicate device	"The results of these tests indicate that the performance of the FibuLink™ device is adequate for its intended use."
Fatigue with pull-to-failure	Adequate durability for intended use; comparable to predicate device	"The results of these tests indicate that the performance of the FibuLink™ device is adequate for its intended use."

Note: The phrase "adequate for its intended use" implies that the results met internal specifications or were comparable to the predicate device, which functioned as the de facto "acceptance criteria" for demonstrating substantial equivalence through non-clinical testing.

The following questions cannot be answered from the provided text as the application explicitly states that clinical testing was not necessary.

Sample sizes used for the test set and the data provenance: Not applicable; no clinical test set mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; no clinical test set mentioned.
Adjudication method for the test set: Not applicable; no clinical test set mentioned.
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 medical device, not an AI/software product, and no clinical studies were performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable; this device is a physical medical device.
The type of ground truth used: Not applicable; no clinical ground truth was established as no clinical testing was performed.
The sample size for the training set: Not applicable; this device is a physical medical device, not an AI/software product, and no training set was used in the context of an algorithm.
How the ground truth for the training set was established: Not applicable; no training set or ground truth in the context of a study was established.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 14, 2017

Akros Medical Charles Horrell CEO and Co-Founder 3503 Pleasant Green Rd Durham, North Carolina 27705

Re: K173550

Trade/Device Name: Akros FibuLink™ Syndesmosis Repair Kit Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HTN Dated: November 15, 2017 Received: November 16, 2017

Dear Charles Horrell:

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

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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); 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.

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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K173550

Device Name

Akros FibuLink™ Syndesmosis Repair Kit

Indications for Use (Describe)

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

区Prescription Use (Part 21 CFR 801 Subpart D)

□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) (Signature)

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K173550 Page 1/2

510(k) Summary
Prepared:	November 15, 2017
Submitter:	Akros Medical3503 Pleasant Green RdDurham, NC 27705
Contact:	Charles HorrellChief Executive Officer and Co-Founder248.259.5535chuck@akrosmedical.com)
Proprietary Name:	Akros FibuLink™ Syndesmosis Repair Kit
Common Name:	Syndesmosis Repair Kit
Regulation and Class:	21 CFR 888.3030 Single/multiple component metallic bonefixation appliances and accessories; Class II
Product Code:	87/HTN
Predicate Device:	Akros FibuLink™ Syndesmosis Repair Kit, K162805 - primary predicate Arthrex TightRope™ Syndesmosis Device, K043248

Device Description:

The current submission is for minor design modifications to the components that make up

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the tibia and fibula anchors and corresponding changes to some of the tools used to install them.

Intended Use / Indications:

Summary of Technologies/Substantial Equivalence:

The modified FibuLink™ Syndesmosis Repair Kit is substantially equivalent to the original device, cleared in K162805, in terms of its intended use and indications, materials, design and mechanical performance. The proposed modifications do not raise new types of safety and effectiveness questions, nor are there new technological issues.

Non-Clinical Testing:

Lateral pull-to-failure, offset load-to-failure, insertion torque, torque-to-failure, fatigue with pull-to-failure, were conducted. The results of these tests indicate that the performance of the FibuLink™ device is adequate for its intended use.

Clinical Testing:

Clinical testing was not necessary to demonstrate substantial equivalence of the FibuLinkTM Syndesmosis Repair Kit to the 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.