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510(k) Data Aggregation
K Number
K192778Device Name
Kinos Axiom Total Ankle System
Manufacturer
Kinos Medical
Date Cleared
2020-06-30
(274 days)
Product Code
HSN
Regulation Number
888.3110Why did this record match?
Applicant Name (Manufacturer) :
Kinos Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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.
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