Mako Shoulder Application (1.0)
MAKO Surgical Corp.The Mako Shoulder Application (1.0) is part of the Mako System designed to assist surgeons in reverse shoulder arthroplasty procedures by providing AI-driven, software-defined spatial boundaries using patient CT imaging. It aids in pre-surgical planning, implant placement, and intraoperative navigation, improving surgical accuracy and outcomes.
Intended Use
The Mako System is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures, specifically reverse shoulder arthroplasty.
Technology
The system includes a robotic arm, an integrated cutting system, an optical detector, computing hardware, dedicated instrumentation, and operating software. It uses patient CT data for preoperative implant placement planning and intraoperative tracking of the patient's scapula, providing haptic guidance and software-defined spatial boundaries to enhance precision in orthopedic shoulder surgery.
Performance
Performance was evaluated through non-clinical testing including software functional testing, cutting system accuracy, reliability, software performance verification, system testing, cadaveric design validation, and summative evaluation, all supporting substantial equivalence to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/9/2024
3 months - 2
FDA Approval
11/7/2024
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