(95 days)
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.
The subject 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 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 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. The subject line extension tibial implant is additively manufactured from Ti-6A1-4V (ASTM F2924) and features a modified stem for fixation into the tibia.
The provided text is a 510(k) Summary for the Kinos Axiom Total Ankle System. It describes the device, its intended use, and its substantial equivalence to predicate devices, but does not contain information about acceptance criteria or specific study results that prove the device meets acceptance criteria.
Specifically, the document lists "Performance Testing" with bullet points for:
- Strength Testing per ASTM F2665
- Bone Stability Testing
- Porous Surface Characterization
- Biocompatibility per ISO 10993-1:2018
However, it does not provide:
- A table of acceptance criteria and reported device performance. It only lists the types of tests conducted.
- Sample sizes used for any test sets.
- Data provenance for any test sets.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication methods.
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
- Information on standalone algorithm performance.
- Type of ground truth used.
- Sample size for any training set.
- How ground truth for a training set was established.
Therefore, I cannot fulfill your request for this information based on the provided text. The document is a regulatory submission demonstrating substantial equivalence, not a detailed report of clinical or performance study results.
§ 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.