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Materialise
Summary: Surgicase Guides by Materialise are used in orthopedic surgeries to assist in precise surgical planning and execution. They are typically used by orthopedic surgeons.
FDA Clearance Information
Pathway
510K
Number
K163156 ↗
Decision Date
January 18, 2017
Product Code
PBF
Device Class
Class 2
Evidence
0 studies
The Surgicase Guides by Materialise were cleared through the FDA 510k pathway on January 18, 2017. They are classified as a Class 2 medical device under product code PBF.
What It Is
Surgicase Guides are patient-specific surgical guides used in orthopedic procedures. They are designed using 3D imaging data to fit the unique anatomy of each patient, aiding surgeons in precise bone cutting and implant positioning. This technology enhances surgical accuracy and outcomes by providing a tailored approach to each surgery.
Clinical Applications
Surgicase Guides are commonly used in orthopedic surgeries such as knee, hip, and shoulder replacements. They are particularly beneficial in complex cases where anatomical variations require customized surgical planning. These guides are used in hospital operating rooms by orthopedic surgeons to improve surgical precision and reduce operative time.
Indications for Use
The FDA-cleared indications for Surgicase Guides involve their use in orthopedic surgeries to assist in accurate bone resections and implant placements. They are intended for patients undergoing procedures that benefit from customized surgical planning.
Practical Considerations
Surgicase Guides are custom-made based on pre-operative imaging, requiring collaboration between the surgical team and the manufacturer. Compatibility with standard surgical instruments and implants is typically ensured, but verification with specific systems is advised.
Frequently Asked Questions
What is Surgicase Guides used for?
Surgicase Guides are used to assist orthopedic surgeons in planning and executing precise bone cuts and implant placements during surgeries.
What specialties typically use this device?
Orthopedic surgeons typically use Surgicase Guides in surgical settings, particularly for joint replacement procedures.
What are the FDA-cleared indications?
Surgicase Guides are indicated for use in orthopedic surgeries to enhance the accuracy of bone resections and implant positioning.
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.