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The restor3d Kinos Axiom Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. The restor3d Kinos Total Ankle System is additionally indicated for patients with failed previous ankle surgery. The restor3d Kinos Axiom Total Ankle System is intended for cement use only.

The subject restor3d Kinos Axiom Total Ankle System is an implant and instrument system 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 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 restor3d Kinos Axiom 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 additively manufactured r3 talar dome and Vitamin E, cross-linked ultra-high molecular weight polyethylene (UHMWPE) r3 bearing component, subject of this 510(k), are compatible with:

• All Kinos Axiom Total Ankle System Tibial Tray Components and associated . instrumentation cleared via K192778
• All Kinos Axiom Total Ankle System X-Stem Tibial Components and associated . instrumentation cleared via K232595

This document is a 510(k) Summary for the restor3d Kinos Axiom Total Ankle System, which is a medical device. It does not describe an AI/ML-based device or a study involving human readers and AI assistance. The performance testing mentioned (ASTM F2665, engineering analyses) pertains to the mechanical and physical properties of the ankle implant, not to the performance of a software algorithm.

Therefore, most of the requested information (e.g., acceptance criteria for AI performance, sample size for test set/training set, ground truth establishment for AI, expert consensus, MRMC studies) is not applicable to this document.

The document discusses:

• Device Name: restor3d Kinos Axiom Total Ankle System
• Regulation Number: 21 CFR 888.3110 (Ankle Joint Metal/Polymer Semi-Constrained Cemented Prosthesis)
• Regulatory Class: Class II
• Product Code: HSN
• Indications for Use: Patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis, or failed previous ankle surgery. Intended for cement use only.
• Predicate Devices: Primarily INFINITY Total Ankle System (K123954) and SALTO TALARIS Total Ankle Prosthesis (K182878).
• Device Description: An implant and instrument system designed to preserve motion in patients with ankle arthritis or previously failed ankle surgery. It's a fixed bearing and semi-constrained implant construct, consisting of a tibial implant, a bearing implant (Vitamin E, cross-linked UHMWPE), and a talar implant (additively manufactured r3 talar dome).
• Performance Testing:
  • Contact Area Testing per ASTM F2665
  • Constraint Testing per ASTM F2665
  • Range of Motion Testing per ASTM F2665
  • Locking Mechanism Fatigue Strength Analysis per ASTM F2665
  • Implant Strength Engineering Analysis per ASTM F2665
  • Wear Engineering Analysis per ASTM F2665
• Conclusion: The device is substantially equivalent to predicate devices, and changes (additively manufactured talar component, Vitamin E cross-linked UHMWPE bearing component, design/size changes) do not raise new safety or effectiveness concerns.

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