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U.S. Department of Health and Human Services

Product Classification

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Device orthopedic computer controlled surgical system
Regulation Description Stereotaxic instrument.
Definition Pre-operative planning and intra-operative execution of surgical movements with robotically controlled end effectors under user supervision. Alternative to manual planning and broaching/reaming techniques for femoral canal preparation in primary total hip arthroplasty (THA).
Physical State Preoperative Planning Workstation, a robotic arm, electronics control cabinet, display monitor and miscellaneous accessories (such as cutters, drapes, irrigation sets, probes and markers).
Technical Method The system registers patient anatomy to a pre-operative surgical plan to guide a robotic arm during the milling of the femeral canal for primary total hip arthroplasty.
Target Area Orthopedic Surgery - Hard tissue.
Regulation Medical Specialty Neurology
Review Panel Orthopedic
Product CodeOJP
Premarket Review Stereotaxic, Trauma and Restorative Devices (DHT6C)
Stereotaxic, Trauma and Restorative Devices (DHT6C)
Submission Type 510(k)
Regulation Number 882.4560
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible