Mako Total Hip Application 5.0
Mako Surgical Corp.The Mako Total Hip Application 5.0 is a surgical assistive system that uses CT image data to create a 3D model of a patient's hip anatomy, helping surgeons plan and perform total hip replacement surgeries with high precision. It incorporates a robotic arm and software to guide implant placement within software-defined boundaries, improving surgical accuracy and patient 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. The system is indicated for use in total hip arthroplasty procedures, including revisions where the acetabular component is well-fixed and can be revised with a cup or wedge augment construct.
Technology
The system consists of a robotic arm, integrated cutting system, optical detector, camera, computer, software, and planning tools. It uses patient-specific CT data to provide preoperative planning, intraoperative navigation, and haptic guidance by constraining surgical tools within spatial boundaries during orthopedic procedures.
Performance
Performance evaluation included software testing, bone registration accuracy verification, bone resection accuracy verification, system verification, and simulated-use cadaveric surgeon validation demonstrating equivalence in safety and effectiveness to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/5/2024
3 months - 2
FDA Approval
3/5/2025
Other devices from Mako Surgical Corp.
- Mako Shoulder Application (1.0)2024 • 510K
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