Foxborough, Massachusetts-based MicroPort NaviBot International LLC, a subsidiary of MicroPort MedBot, has received FDA 510(k) clearance for the SkyWalker™ Total Knee System.
510(k) Clearance for SkyWalker Total Knee System
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The SkyWalker System is MicroPort NaviBot’s first robot-assisted platform for orthopedic applications. SkyWalker will provide a “robotically assisted total knee replacement solution that is compatible with the Evolution® Medial-Pivot total knee system.” The system prioritizes safety while also ensuring “precise operation and efficient coordination.”
According to the 510(k) Summary, the SkyWalker Total Knee System is “intended to assist the surgeon to perform Total Knee Arthroplasty (TKA) procedures by providing software-defined spatial boundaries for orientation and reference information to anatomical structures for the accurate placement of compatible knee implant components.” The SkyWalker Total Knee System is indicated for use in TKA procedures in which “the selection of stereotactic surgery is appropriate, and the anatomical bony structures can be identified with a CT based model.”
The system includes the following: “surgical console (a robotic arm platform), navigation console (an optical tracking navigation platform), software system (including preoperative planning software), cables, surgical instruments and accessories.” The robotic arm placement is “performed relative to anatomical landmarks as recorded using the system intraoperatively and based on a preoperative plan derived from imported CT images.”
In order to qualify for the shorter and earlier 510(k) clearance the device must be substantially equivalent to a predicate device. The SkyWalker Total Knee System is substantially equivalent to the ROSA Knee System.
The system’s unique capabilities include the ability to provide information to the surgeon that helps the surgeon, per the press release, “achieve the desired joint line reconstruction while providing data to optimally balance soft tissues.”
MicroPort NaviBot International LLC submitted the 510(k) application. Incorporated in 2020, MicroPort NaviBot, along with MicroPort Orthopedics, plans to create additional orthopedic applications to expand its orthopedic offerings.
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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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