The Kinos Axiom Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis.

The Kinos Total Ankle System is additionally indicated for patients with failed previous ankle surgery.

The Kinos Axiom Total Ankle System is intended for cement use only.

Device Description

The subject Kinos Axiom Total Ankle System is an implant and instrument system designed to preserve motion in patients with ankle arthritis. The device is a fixed bearing and semi-constrained implant construct, intended for replacement of the articulating surfaces of the ankle that have been affected by a disease state or injury. The device provides limited mobility to a patient by restoring alignment of the articulating surfaces, reducing pain and providing flexion-extension movement within the ankle joint. The device is intended to be used with bone cement. The subject Kinos Axiom Total Ankle System comprises three implant components – a tibial implant affixed to the tibia, a bearing implant assembled to the tibial implant and talar implant affixed to the talus. The tibial implant and bearing implant, assembled intraoperatively, function together and articulate with the talar implant to create a fixed bearing prosthesis, replacing the articulating surface of the tibial-talar joint.

AI/ML Overview

This document describes a medical device submission (K192778) for the Kinos Axiom Total Ankle System. It does not contain information about acceptance criteria or a study proving device performance as typically understood in the context of an Artificial Intelligence (AI) or machine learning device.

The Kinos Axiom Total Ankle System is a physical implant, not a software or AI-driven diagnostic/prognostic device, so the usual metrics associated with AI device performance (like sensitivity, specificity, AUC) and relevant study designs (like MRMC studies) are not applicable here.

The "studies" mentioned are non-clinical analyses of the physical implant's mechanical properties, material safety, and biocompatibility, which are standard for orthopedic implants.

Here's a breakdown of the requested information based only on the provided text, acknowledging that many categories will be N/A due to the nature of the device:

A table of acceptance criteria and the reported device performance

Acceptance Criteria: The document states that the non-clinical analysis shows the device "can be expected to perform at least as well as the legally marketed predicates referenced above." The specific quantitative acceptance criteria (e.g., minimum fatigue life, maximum wear rate) from the ASTM and ISO standards would be detailed in the full submission, but are not provided in this summary.
Reported Device Performance: The summary indicates that the "results of this analysis show that the subject Kinos Axiom Total Ankle System can be expected to perform at least as well as the legally marketed predicates referenced above." No specific quantitative performance metrics are provided in this summary.

Acceptance Criteria (General)	Reported Device Performance (General)
Performed at least as well as predicate devices	Performed at least as well as predicate devices based on non-clinical analyses (Fatigue, Constraint, Contact Area, Strength, Wear, Range of Motion, Biocompatibility, Pyrogenicity)

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 applicable in the context of an observational/clinical test set for AI. The "test set" here refers to physical samples of the implant undergoing mechanical and biological testing. The specific number of implant samples for each test (e.g., how many underwent fatigue testing) is not specified.
- Data Provenance: Not applicable in the context of patient data. The "data" comes from engineering and laboratory testing of the device itself.
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. Ground truth for an AI device involves expert consensus on medical images or clinical outcomes. For this physical implant, performance is assessed against engineering standards and material properties, not clinical expert readings.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is relevant for clinical outcome adjudication or image interpretation, not for mechanical testing of a physical device.
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
- No. Not applicable, as this is a physical implant, not an AI-assisted diagnostic tool. No clinical study or MRMC study was required for its 510(k) clearance ("n/a – no clinical evidence was required to determine substantial equivalence").
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical tests, the "ground truth" is defined by established engineering and biological standards (e.g., ASTM F2665 for fatigue and wear, ISO 10993-1 for biocompatibility). The device's performance is compared against the requirements and benchmarks set by these standards and against the performance of predicate devices.
The sample size for the training set
- Not applicable. This is not an AI device that requires a training set.
How the ground truth for the training set was established
- Not applicable.

Summary

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June 30, 2020

Image /page/0/Picture/1 description: The image shows 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.

Kinos Medical % Alyssa Schwartz Regulatory Consultant Alyssa Schwartz 992 Old Eagle School Road Suite 907 Wayne, Pennsylvania 19087

Re: K192778

Trade/Device Name: Kinos Axiom Total Ankle System Regulation Number: 21 CFR 888.3110 Regulation Name: Ankle Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: HSN Dated: May 22, 2020 Received: May 26, 2020

Dear Alyssa Schwartz:

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 identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (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-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and 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 the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/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, Ph.D., R.A.C. Acting 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) K192778

Device Name

Kinos Axiom Total Ankle System

Indications for Use (Describe)

The Kinos Axiom Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis.

The Kinos Total Ankle System is additionally indicated for patients with failed previous ankle surgery.

The Kinos Axiom Total Ankle System is intended for cement use only.

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)	☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the Kinos Axiom Total Ankle System.

1.	Submitted By:	Brian GarveyCEOKinos Medical992 Old Eagle School Rd, Suite 907Wayne, PA 19087
	Date:	June 30, 2020
	Contact Person:	Alyssa Schwartz, MS, RACRegulatory Affairs ConsultantKinos Medical992 Old Eagle School Rd, Suite 907Phone: (610) 806-6895Email: aschwartzconsulting@gmail.com
2.	Proprietary Name:	Kinos Axiom Total Ankle System
	Common Name:	Ankle Prosthesis
	Classification Name and Reference:	21 CFR 888.3110, Class II
	Device Product Code and Device Panel:	HSN: Orthopedic
3.	Predicate Device:	K123954 and K140749Wright MedicalInfinity Total Ankle System

4. Device Description

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ട. Intended Use
Intended Use:

The Kinos Axiom Total Ankle System is intended to provide a patient with limited mobility by restoring alignment, reducing pain and replacing the flexion/extension movement of the ankle joint.

Indications for Use:

The Kinos Axiom Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.

The Kinos Total Ankle System is additionally indicated for patients with failed previous ankle surgery.

The Kinos Axiom Total Ankle System is intended for cement use only.

1. Technological Characteristics Comparison
  The general technological features of the Kinos Axiom Total Ankle System are similar to the predicate devices with regard to design and materials.
1. Substantial Equivalence – Non-Clinical Evidence
  The following non-clinical analysis was performed:
Fatigue, Constraint, Contact Area, Strength Testing and Wear Performance and Range of Motion Analyses per ASTM F2665
. Biocompatibility per ISO 10993-1: 2018
Pyrogenicity per ANSI/AAMI/ST72: 2011 ●

The results of this analysis show that the subject Kinos Axiom Total Ankle System can be expected to perform at least as well as the legally marketed predicates referenced above. The safety and effectiveness of the Kinos Axiom Total Ankle System is adequately supported by the substantial equivalence information, materials information, and comparison of design characteristics provided within this 510(k) submission.

1. Substantial Equivalence - Clinical Evidence
  n/a – no clinical evidence was required to determine substantial equivalence
1. Substantial Equivalence – Conclusions
  The design characteristics of 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 systems.

Regulation Number and Section

§ 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.