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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
510K
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.
Clinical Applications
This device is commonly used in orthopedic surgeries, such as joint replacements and corrective bone surgeries. It is particularly beneficial in complex cases where precision is crucial. Orthopedic surgeons in hospital settings or specialized surgical centers typically use this system. The device is suitable for adult patients undergoing elective orthopedic procedures.
Indications for Use
The FDA-cleared indications for the Surgicase Orthopaedics System involve its use in surgical planning and guidance for orthopedic procedures. It is intended for patients requiring precise surgical interventions, such as those undergoing joint replacements.
Practical Considerations
The system is compatible with standard imaging modalities like CT and MRI, allowing for integration with existing hospital infrastructure. Surgeons should ensure accurate imaging data for optimal guide creation. The guides are typically custom-made for each patient, requiring pre-surgical planning time.
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.