The FDA has 510(k) cleared the second total ankle on the market with patient CT guided technology.
Total Ankle With Patient CT Guided Tech Cleared by FDA
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Secondary#totalanklereplacement#anklepain
On January 29, 2020, after an eight-month review, the FDA cleared Memphis-based In2Bones Global, Inc.’s Quantum Total Ankle. The agency determined it was substantially equivalent to three other total ankles on the market.
While substantially equivalent to competing ankles, the company stated that compared to current total ankles on the market, “the anatomically designed talus with a dual radius of curvature improves the dorsi and plantar flexion of the patient. In addition, the Quantum system has a unique cruciate shaped vertical stem in the tibia to provide unsurpassed stability and fixation upon impaction.”
The Quantum includes the patient-specific instrumentation (PSI) called, OrthoPlanify. The instrumentation, according to the company, is designed to allow a surgeon to “modify, adjust and manipulate the views and utilize 3D-printed guides in surgery for precision bone cuts.”
Jon Simon, the company’s marketing VP said, “There is a huge need for innovation in PSI for the total ankle, and the benefit to the surgeon and the patient with OrthoPlanify far exceeds what’s currently available to them.”
The FDA clearance document states the device is indicated “as a total ankle replacement in primary or revision surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.” In the US, the device is only intended for cement use.
The Quantum is a fixed-bearing total ankle replacement device composed of a tibial implant, a tibial inlay, and a talar implant. “Both the tibial implant and talar implant are secured to patient anatomy via bone cement; the intermediate inlay is rigidly fixed to the tibial implant intra-operatively. When all three components are implanted, the intermediate inlay acts as a bearing along the talar implant, enabling movements at the replaced joint.”
Components are available in a variety of sizes and design configurations to accommodate anatomical needs of a patient’s ankle joint and intended for both primary and revision applications. The device is accompanied by a complete instrumentation set including trial and drill/cutting guide.
The company said it will begin a controlled market release of the device in summer 2020, with a full market launch set for the first quarter of 2021.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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