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urethane orthopaedic casting tape
Hexcel Medical
Summary: The urethane orthopaedic casting tape is a medical device used for immobilizing fractures and supporting injured limbs. It is primarily used by orthopaedic specialists and emergency care providers.
FDA Clearance Information
Pathway
510K
Number
K811164 ↗
Decision Date
May 27, 1981
Product Code
ITG
Device Class
Class 1
Evidence
0 studies
The urethane orthopaedic casting tape by Hexcel Medical was cleared via the FDA 510k pathway on May 27, 1981. It is classified as a Class 1 device under product code ITG.
What It Is
The urethane orthopaedic casting tape is a synthetic casting material used to immobilize and support fractured or injured limbs. Made from polyurethane, it offers a lightweight and durable alternative to traditional plaster casts. It hardens quickly upon exposure to moisture, providing a rigid support structure that conforms to the body's contours.
Clinical Applications
This device is commonly used in orthopaedic and emergency settings for the treatment of fractures, sprains, and other musculoskeletal injuries. It is particularly useful in outpatient clinics and hospitals where quick application and patient comfort are priorities. The tape is suitable for a wide range of patients, from children to adults, requiring immobilization for healing.
Indications for Use
The device is indicated for use in patients requiring immobilization of fractures or support for injured limbs. It is suitable for conditions where stabilization is necessary to promote healing and prevent further injury.
Practical Considerations
The casting tape is available in various widths to accommodate different limb sizes and injury types. It is compatible with standard casting techniques and can be easily molded to fit the contours of the body. Proper application technique is essential to ensure optimal support and patient comfort.
Frequently Asked Questions
What is urethane orthopaedic casting tape used for?
It is used for immobilizing fractures and supporting injured limbs to promote healing.
What specialties typically use this device?
Orthopaedic specialists and emergency care providers commonly use this device.
What are the FDA-cleared indications?
It is indicated for immobilization of fractures and support of injured limbs.
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.