Kinos Axiom Total Ankle System

K192778 · Kinos Medical · HSN · Jun 30, 2020 · Orthopedic

Device Facts

• Record ID: K192778
• Device Name: Kinos Axiom Total Ankle System
• Applicant: Kinos Medical
• Product Code: HSN · Orthopedic
• Decision Date: Jun 30, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3110
• Device Class: Class 2
• Attributes: Therapeutic

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. 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.

Device Story

The Kinos Axiom Total Ankle System is a fixed-bearing, semi-constrained orthopedic implant designed to replace articulating surfaces of the ankle joint. It consists of three components: a tibial implant, a talar implant, and an intermediate bearing implant. The system is implanted by a surgeon to restore joint alignment, reduce pain, and facilitate flexion-extension movement in patients with severe arthritis or failed prior surgery. The device is intended for use with bone cement. It functions as a mechanical replacement for the natural tibial-talar joint, providing limited mobility and structural support to the ankle.

Clinical Evidence

No clinical evidence was required to determine substantial equivalence. Evidence is based on non-clinical bench testing, including fatigue, constraint, contact area, strength, wear performance, and range of motion analyses per ASTM F2665, biocompatibility per ISO 10993-1:2018, and pyrogenicity per ANSI/AAMI/ST72:2011.

Technological Characteristics

Fixed-bearing, semi-constrained ankle prosthesis. Components: tibial implant, talar implant, and bearing implant. Intended for cemented use. Testing performed per ASTM F2665 (fatigue, constraint, contact area, strength, wear, range of motion), ISO 10993-1:2018 (biocompatibility), and ANSI/AAMI/ST72:2011 (pyrogenicity).

Indications for Use

Indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis, or those with failed previous ankle surgery.

Regulatory Classification

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).

Predicate Devices

• Infinity Total Ankle System (K123954)
• Infinity Total Ankle System (K140749)

Submission Summary (Full Text)

{0}------------------------------------------------

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

{1}------------------------------------------------

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 ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

# 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) | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| <table><tr><td><span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span></td></tr><tr><td><span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span></td></tr></table> | <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
| <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | | |
| <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | | |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

### 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 Garvey<br>CEO<br>Kinos Medical<br>992 Old Eagle School Rd, Suite 907<br>Wayne, PA 19087 |
|----|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Date: | June 30, 2020 |
| | Contact Person: | Alyssa Schwartz, MS, RAC<br>Regulatory Affairs Consultant<br>Kinos Medical<br>992 Old Eagle School Rd, Suite 907<br>Phone: [phone]<br>Email: [e-mail] |
| 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 K140749<br>Wright Medical<br>Infinity Total Ankle System |

#### 4. 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.

{4}------------------------------------------------

- 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.

- 6. 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.

- 7. 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.

- 8. Substantial Equivalence - Clinical Evidence
n/a – no clinical evidence was required to determine substantial equivalence

- 9. 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.