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510(k) Data Aggregation
K Number
K213873Device Name
SkyWalker Total Knee System
Manufacturer
Date Cleared
2022-07-07
(206 days)
Product Code
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
MicroPort NaviBot International LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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.
It 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.
SkyWalker Total Knee System includes 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.
The targeted population as well as indications have the same characteristics as those suitable for the following implants compatible with SkyWalker Total Knee System: EVOLUTION® MP TOTAL KNEE SYSTEM, EVOLUTION® MP TOTAL KNEE SYSTEM, ADVANCE® STATURE FEMORAL COMPONENT, ADVANCE® TIBIAL COMPONENT, and ADVANCE® KNEE SYSTEM.
Device Description
SkyWalker Total Knee System consists of a navigation console, a surgical console, cables, software system, surgical instruments and disposables. The navigation console includes a navigation trolley, an optical tracking device, a primary monitor and a surgeon monitor. The surgical console includes a robotic arm, a robotic arm trolley and a foot pedal.
The TKA surgery workflow under the guidance of SkyWalker Total Knee System can be divided into preoperative procedure and intraoperative procedure. The preoperative procedure is to assist the user with preoperative planning by using patient CT image data and providing reference information to anatomical structures to make a surgical plan for the TKA surgery. In the intraoperative procedure, Skywalker Total Knee System can provide stereotactic guidance for real-time orientation of the cutting block to a target position with a target pose. When the robotic arm reaches the target position, the cutting block is being held in an expected pose, then the surgeon could be able to accurately perform knee resection.
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