(91 days)
The INBONE® Total Ankle is indicated for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis. The INBONE® Total Ankle is additionally indicated for patients with a failed previous ankle surgery. CAUTION: The ankle prosthesis is intended for cemented use only.
The INBONE® implant is a total ankle replacement (TAR) that is made of several specific components. A key concept of the INBONE® device is its modularity. Based on patient anatomy, a number of component sizes can be optioned for best fit. These components include the tibial stem components, the tibial tray, the poly bearing, the talar dome, and the talar stem.
This document is a 510(k) summary for the INBONE® Total Ankle System Line Extension. It's a premarket notification to the FDA to demonstrate substantial equivalence to previously cleared devices. It does not describe a study involving algorithms, AI, or human readers, nor does it provide acceptance criteria for such a system.
Therefore, I cannot provide the requested information, such as:
- A table of acceptance criteria and reported device performance
- Sample sizes for a test set or training set
- Data provenance
- Number/qualifications of experts to establish ground truth
- Adjudication method
- MRMC comparative effectiveness study results or effect size
- Standalone algorithm performance
- Type of ground truth used
The document focuses on the physical characteristics and safety/effectiveness of a medical implant (an ankle prosthesis). The substantial equivalence is based on:
- Non-Clinical Evidence: Performance testing and engineering analysis related to articular shear stability, contact pressure, and lock detail.
- Technological Characteristics Comparison: Addition of a Size 1 Talar Dome and Size 1+ Poly Bearing, thicker poly bearings for revisions, trials for new poly bearings and the size 1 talar dome, and mid and top tibial stem pieces with plasma coating removed.
In summary, this document is about a mechanical medical device, not an AI or algorithm-based device.
§ 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.