The SixFix® Hexapod Fixator is intended to be used for post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; open and closed fracture fixation; pseudo-arthrosis of long bones; limb lengthening by epiphyseal or metaphyseal distraction of bony or soft tissue deformities; correction of bony or soft tissue defects; joint arthrodesis; infected fractures or nonunions.

Device Description

The SixFix Hexapod Fixator is a multilateral circular external fixation system. The system includes the following external fixator elements: rings, arches, struts, threaded rods, reduction struts, and assembly accessories. All the elements are provided non-sterile and are for single use only.

AI/ML Overview

This document is a 510(k) summary for "Accessories for the SixFix Hexapod Fixator". It is a premarket notification for a Class II medical device, and therefore a clinical study to prove the device meets acceptance criteria is not typically required. This 510(k) summary describes a performance data study, specifically a mechanical testing study, rather than a clinical study involving human patients or a complex algorithm.

Here's a breakdown of the information requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Comparable mechanical performance to predicate device	SixFix Reduction Struts exhibited results comparable to the predicate device in static axial compression testing.
Slightly greater stiffness than predicate device (implied beneficial outcome)	SixFix Reduction Struts possessed a slightly greater stiffness than the predicate device.
No new concerns related to safety and effectiveness	Confirmed by comparison of indications, material, design, and technological characteristics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not explicitly stated in terms of a number of devices or tests. The document refers to "The SixFix Reduction Struts" in the plural, implying multiple units were tested, but a specific quantity is not given.
Data Provenance: Not explicitly stated. This was mechanical testing, likely conducted by the manufacturer or a contracted testing facility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. This was a mechanical engineering study, not a clinical study requiring expert interpretation of medical data. The "ground truth" would be the measured physical properties of the tested components.

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

Not Applicable. As a mechanical engineering study, there is no "adjudication method" in the clinical sense. The results are direct measurements.

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 device is a mechanical external fixator accessory, not an AI-assisted diagnostic or treatment device.

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

Not Applicable. This device is a mechanical external fixator accessory, not an algorithm.

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

Mechanical properties/measurements: The ground truth for this mechanical performance study would be the measured forces, displacements, and stiffness values obtained during the ASTM F1541 static axial compression testing.

8. The sample size for the training set

Not Applicable. This is not a machine learning device; therefore, there is no "training set."

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

Not Applicable. As there is no training set for a machine learning model, this question is irrelevant to this device submission.

Summary

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September 22, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food & 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.

Thomas Twardzik VP - Marketing and Operations 328 Poplar View Lane East, Suite 2 Collierville, Tennessee 38017

Re: K200123

Trade/Device Name: Accessories for the SixFix® Hexapod Fixator Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: KTT Dated: August 18, 2020 Received: August 19, 2020

Dear Thomas Twardzik:

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 product submissions. The general controls provisions of the Act include requirements for annual registration. Iisting 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 device-related adverse events) (21 CFR 803) for devices or

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safety reporting (21) CFR CFR 4, Subpart B) for combination products postmarketing (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-reporting-mdr-howreport-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and a 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 website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe DICE assistance/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,

Ting Song Assistant Director DHT6A: Division of Joint Arthroplasty 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) K200123

Device Name Accessories for the SixFix® Hexapod Fixator

Indications for Use (Describe)

INDICATIONS for Accessories for the SixFix Hexapod Fixator (Reduction Struts, Foot Arches with Locking Hinges, Motion Hinge, Variable Angle Clamps)

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 K200123 Accessories for the SixFix® Hexapod Fixator

I. Submitter:

Arrowhead Medical Device Technologies, LLC 328 Poplar View Lane East, Suite 2 Collierville, TN 38017

Contact Person: Thomas J. Twardzik Vice President, Marketing and Operations Office: (901) 853-4366 Fax: (206) 222-9173 Email: INFO@ArrowheadDevices.com

Date of Summary: September 17, 2020

II: Device

Proprietary Name: Accessories for the SixFix® Hexapod Fixator Common Name: External Fixator Regulatory Class: Class II Regulation: 21 CFR 888.3030 Single/multiple component metallic bone fixation appliances and

accessories

Device Product Codes: KTT

Panel: Orthopedic

III. Predicate Devices

Device	Manufacturer	510(k) No.	ClearanceDate
Primary Predicate
SixFix Hexapod Fixator	AMDT	K190069	May 14, 2019
Secondary Predicates
TL-HEX TRUELOK ExternalFixation System	Orthofix Srl	K141078	September 2, 2014
Hoffman LRF System	Stryker GmbH	K161753	November 15, 2016
		K163656	April 14, 2017
		K182968	January 25, 2019

IV. Device Description

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510(k) Summary K200123 Accessories for the SixFix® Hexapod Fixator

V. Intended Use

INDICATIONS for Accessories for the SixFix Hexapod Fixator (Reduction Struts, Foot Arches with Locking Hinge, Variable Angle Clamps)

The SixFix®Hexapod is intended to be used for post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in ioint contractures or loss of range of motion and fractures vrequiring distraction; open and closed fracture fixation; pseudo-arthrosis of long bones; limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformities; correction of bony or soft tissue defects; joint arthrodesis; infected fractures or nonunions.

VI. Comparison of Technological Characteristics with the Predicate Devices

The accessories used with the SixFix Hexapod Fixator are technologically substantially equivalent to predicate devices in terms of intended use, material, design, mechanical performance, and safety. Comparisons confirmed that the accessories used with the SixFix Hexapod Fixator are substantially equivalent when compared to those accessories used with the predicate device. The design characteristics of the accessories used with the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate device.

VII. Performance Data

The SixFix Reduction Struts were compared to the predicate device in accordance to ASTM F1541 static axial compression testing. The SixFix Reduction Struts exhibited results comparable to the predicate device in addition to possessing a slightly greater stiffness than the predicate device. Because there are no new concerns related to safety and effectiveness, it can be determined that the SixFix Reduction Struts are substantially equivalent to the predicate devices.

VIII. Conclusions

A review of the device indications, material composition, external element design, and technological characteristics confirmed that the accessories used with the SixFix Hexapod Fixator are substantially equivalent to the predicate devices. While the accessories used with the SixFix Hexapod Fixator are not identical to the predicate devices, comparisons of the subject and predicate device confirmed that any differences between the subject device and predicate do not render the device NSE as there is not a new intended use; and any differences in technological characteristics do not raise different questions of safety and effectiveness than the predicate device. Therefore, it is concluded that the accessories used with the SixFix Hexapod Fixator are substantially equivalent to the predicate devices.

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.