Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
Materialise N.V.The Materialise Shoulder System is a patient-specific medical device designed to assist surgeons in preoperative planning and intraoperative positioning of shoulder replacement components. It includes the SurgiCase Shoulder Planner software, which utilizes CT imaging to generate detailed 3D pre-surgical plans. Based on these plans, patient-specific guides and models are created to help precisely position implants during surgery, improving surgical accuracy and outcomes for total and reverse shoulder arthroplasty.
Intended Use
The Materialise Shoulder Guide and Models are intended as surgical instruments to assist in intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks identifiable on preoperative CT scans. The software, SurgiCase Shoulder Planner, is intended as a pre-surgical planner for simulating shoulder orthopedic surgery interventions and assisting in positioning shoulder components.
Technology
The system comprises software (SurgiCase Shoulder Planner) that enables surgeons to visualize, measure, reconstruct, annotate, and edit a patient-specific pre-surgical plan based on CT images. It then generates a surgical plan report and pre-surgical data files used to design patient-specific guides and models for intraoperative use. The guides fit the patient's anatomy precisely to transfer the virtual preplanning to surgery. The software shares the same code base and technology principles as the predicate device and extends compatibility with multiple shoulder implant systems.
Performance
Non-clinical performance testing demonstrated adequate accuracy, biocompatibility, sterility, and stability of the hardware guides. Software verification and validation followed FDA guidance for medical device software, confirming that technological differences from the predicate do not raise new safety or effectiveness questions. Previous simulated surgeries on rapid prototyped bone models and cadaver tests support the device's performance.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/18/2024
1 month - 2
FDA Approval
10/18/2024
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.