đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Immobilization of fractures.
- Support and stabilization of injured limbs.
- Use when external immobilization is needed to promote healing and help prevent further injury.
Clinical Applications
- Casting and immobilization of fractured arms, legs, hands, feet, or other extremities.
- Support of injured limbs after musculoskeletal trauma.
- Stabilization of sprains or similar injuries when immobilization is clinically indicated.
- Application of temporary or definitive external casts in orthopaedic clinics, emergency departments, hospitals, and outpatient settings.
Practical Considerations
- Available widths should be selected according to the patient's limb size, the anatomic location, and the amount of support required.
- The tape is activated by moisture and should be applied promptly after wetting according to the product instructions.
- Proper padding, molding, and monitoring are important to reduce pressure injury, skin irritation, swelling-related problems, and impaired circulation.
- The material is compatible with standard casting techniques, but removal generally requires a cast saw or other appropriate cast-removal method.
- A cured polyurethane cast is generally considered MRI compatible because it contains no metal, but any associated splints, clips, or embedded materials should be checked before MRI.
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.