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510(k) Data Aggregation
K Number
K220774Device Name
RobPath® Total Hip Application
Manufacturer
Date Cleared
2022-12-09
(268 days)
Product Code
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
Hangzhou Lancet Robotics Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The RobPath® Total Hip Application is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The RobPath® Total Hip Application is indicated for use in a surgical hip procedure in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include:
• Total Hip Arthroplasty (THA)
Device Description
The proposed RobPath® Total Hip Application is a semi-active robotic system. Pre-operative CT imaging is used to generate a 3D model of the native hip joint. An initial plan is created using selected CT landmarks and superimposed onto the 3D reconstruction. The surgeon is then able to fine-tune this to ensure optimal templating of component size and alignment, thus allowing the desired restoration of hip biomechanics, bone coverage, component positioning and leg-length correction. The robotic arm is not fully automated but based on haptic feedback, so the surgeon retains partial control during the implantation.
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