(274 days)
Not Found
No
The summary describes a mechanical implant system for ankle replacement and does not mention any AI or ML components or functionalities.
Yes
The device is an implant designed to replace damaged ankle joints, restoring alignment, reducing pain, and providing movement, which are all therapeutic functions.
No
Explanation: This device is an implantable medical device (total ankle system) designed to replace damaged ankle joints and restore motion, not to diagnose medical conditions.
No
The device description clearly states it is an "implant and instrument system" comprising physical components (tibial implant, bearing implant, talar implant) intended for surgical implantation, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Kinos Axiom Total Ankle System is an implant and instrument system designed to replace the articulating surfaces of the ankle joint. It is a physical device implanted into the body.
- Intended Use: The intended use is to treat damaged ankle joints caused by arthritis or failed previous surgery by replacing the joint. This is a surgical intervention, not a diagnostic test performed on a sample.
The description clearly indicates a surgically implanted device, which falls under the category of medical devices, but not specifically in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HSN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle joint, tibia, talus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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 (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
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) | ||
|---|---|---|
| ☒ 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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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
CEO
Kinos Medical
992 Old Eagle School Rd, Suite 907
Wayne, PA 19087 |
|----|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Date: | June 30, 2020 |
| | Contact Person: | Alyssa Schwartz, MS, RAC
Regulatory Affairs Consultant
Kinos Medical
992 Old Eagle School Rd, Suite 907
Phone: (610) 806-6895
Email: 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 K140749
Wright Medical
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.
-
- 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.
- Technological Characteristics Comparison
-
- Substantial Equivalence – Non-Clinical Evidence
The following non-clinical analysis was performed:
- Substantial Equivalence – Non-Clinical Evidence
-
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.
-
- Substantial Equivalence - Clinical Evidence
n/a – no clinical evidence was required to determine substantial equivalence
- Substantial Equivalence - Clinical Evidence
-
- 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.
- Substantial Equivalence – Conclusions