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FDA 510(k)

Kinos Axiom Total Ankle System

K-Number: K192778 · 2020-06-30

ApplicantKinos Medical
Decision Date2020-06-30
Product CodeHSN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Kinos Axiom Total Ankle System is a medical device manufactured by Kinos Medical. It received FDA 510(k) clearance on 2020-06-30 under approval number K192778. The device is classified under product code HSN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Kinos Axiom Total Ankle System?

Kinos Axiom Total Ankle System is a medical device that received FDA 510(k) clearance on 2020-06-30. It is manufactured by Kinos Medical. The 510(k) number is K192778.

When was Kinos Axiom Total Ankle System approved by the FDA?

Kinos Axiom Total Ankle System received FDA 510(k) clearance on 2020-06-30, under approval number K192778.

What company makes Kinos Axiom Total Ankle System?

Kinos Axiom Total Ankle System is manufactured by Kinos Medical.

What is the FDA product code for Kinos Axiom Total Ankle System?

The FDA product code for Kinos Axiom Total Ankle System is HSN.

Related Clinical Trials

NCT07191067 Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty RECRUITING NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT04325022 Safety and Effectiveness Study of OR3O™ Dual Mobility System in THA ACTIVE_NOT_RECRUITING NCT00453505 Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System COMPLETED

Related PubMed Literature

PMID: 41209898 Evaluation of a Single Knee System: All-Polyethylene Tibia (APT) vs. Metal-Backed Tibia (MBT) in Primary Total Knee Arthroplasty. Cureus (2025) PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024) PMID: 29258356 Grave fraudulence in medical device research: a narrative review of the PIN seeding study for the Pinnacle hip system. Accountability in research (2018) PMID: 28280294 Assessing the cost burden of United States FDA-mandated post-approval studies for medical devices. Journal of health care finance (2016)

Related Devices (Code: HSN)

K153452Salto XT, Salto TalarisTornier S.A.S. K153008INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc K152217Exactech Vantage Total Ankle SystemExactech, Inc. K171004Hintermann Series H2 Total Ankle SystemDt Medtech, LLC K171067INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc K170968PROPHECY INVISION Pre-operative Navigation SystemWrightmedicaltechnologyinc

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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