Search Results

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

The subject Kinos Total Ankle System consists of implant and instrument components designed to preserve motion in patients with ankle arthritis or previously failed ankle surgery. 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 subject 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 tibial and talar implants are intended to be used with bone cement. The subject Kinos Total Ankle System consists of three implant components – a tibial implant affixed to the tibia, a bearing implant assembled to the tibial implant and a 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 tibiotalar joint. The subject line extension includes additional intermediate sizes for the tibial implants. Additionally, the line extension introduces steam (moist heat) sterilization for the tibial implants for sterilization on-site at the hospital.

The Kinos Total Ankle Tibial Implants subject of this 510(k), are compatible with:

• All Kinos Axiom Total Ankle System Talar and Bearing Components and associated instrumentation cleared via K192778
• All Kinos Axiom Total Ankle System r3 Talar and Vitamin E Bearing Components and associated instrumentation cleared via K240591

N/A

Ask a specific question about this device