đź“‹ FDA Reference
Surgicase Orthopaedics System Surgicase Connect Surgicase Guides
Materialise
Summary: The Surgicase Orthopaedics System by Materialise is a customizable surgical planning and guide system used primarily in orthopedic procedures. It is utilized by orthopedic surgeons to enhance precision in surgeries.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K132290 ↗
Decision Date ?
April 10, 2014
Product Code ?
PBF
Device Class ?
Class 2
Evidence ?
0 studies
The Surgicase Orthopaedics System was cleared through the FDA 510(k) pathway on April 10, 2014. Manufactured by Materialise, it is classified as a Class 2 medical device under product code PBF.
What It Is
The Surgicase Orthopaedics System is a software and guide system designed to assist orthopedic surgeons in pre-operative planning and intra-operative guidance. It uses patient-specific data to create surgical guides that enhance the precision of bone cuts and implant placements. The system integrates with imaging data to provide a tailored approach to each surgical case, improving outcomes and reducing surgical times.
FDA-Cleared Indications
- Preoperative planning for orthopedic surgical procedures.
- Creation of patient-specific surgical guides for orthopedic procedures.
- Intraoperative guidance for planned orthopedic bone cuts and implant positioning.
Clinical Applications
- Patient-specific planning for orthopedic surgery.
- Custom guidance during bone-cutting procedures.
- Guidance for positioning orthopedic implants when included in the planned procedure.
- Planning and guidance for complex or anatomy-specific orthopedic cases.
Practical Considerations
- The system depends on accurate patient imaging and clinical information for planning and guide fabrication.
- Guides are patient-specific and require time for image processing, surgical planning, review, and production before surgery.
- The FDA record identifies product code PBF and does not establish universal compatibility with every imaging system, implant, or operating-room workflow; compatibility should be confirmed for each case.
- The provided FDA summary does not establish that the surgical guides are intended for MRI use or that they are independently MRI safe. MRI labeling should be checked for the specific guide materials and components.
- The system supports surgical planning and guidance but does not replace the surgeon's clinical judgment, standard surgical technique, or the implant manufacturer's instructions.
Frequently Asked Questions
What is Surgicase Orthopaedics System used for?
It is used for pre-operative planning and intra-operative guidance in orthopedic surgeries to enhance precision and outcomes.
What specialties typically use this device?
Orthopedic surgeons specializing in joint replacement and corrective bone surgeries typically use this device.
What are the FDA-cleared indications?
The device is indicated for surgical planning and guidance in orthopedic procedures, particularly for precise bone cuts and implant placements.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.