đź“‹ FDA Reference
American Orthopaedic Cast Cutter Model 0295-200
Martin Medical
Summary: The American Orthopaedic Cast Cutter Model 0295-200 by Martin Medical is a device used to safely remove orthopedic casts. It is primarily used by orthopedic surgeons and clinicians in hospital and outpatient settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K861074 ↗
Decision Date ?
March 28, 1986
Product Code ?
LGF
Device Class ?
Class 1
Evidence ?
0 studies
The American Orthopaedic Cast Cutter Model 0295-200 was cleared through the FDA 510(k) pathway on March 28, 1986. Manufactured by Martin Medical, it is classified as a Class 1 device under product code LGF.
What It Is
The American Orthopaedic Cast Cutter Model 0295-200 is a specialized tool designed to remove orthopedic casts without causing injury to the patient. It operates by oscillating a small blade that can cut through the hard material of the cast while minimizing the risk of cutting the skin underneath. This device is essential in orthopedic care for the safe and efficient removal of casts.
FDA-Cleared Indications
- Removal of orthopedic casts.
- Removal of cast material used to immobilize and protect injured or fractured limbs.
Clinical Applications
- Removing plaster orthopedic casts.
- Removing fiberglass or other compatible synthetic casts when appropriate for the instrument and blade.
- Removing casts during follow-up care after fracture treatment.
- Removing casts in orthopedic clinics, hospitals, emergency departments, and outpatient settings.
Practical Considerations
- Use the blade size and accessory recommended for the cast thickness and material.
- The operator should use appropriate technique, skin protection, and inspection during cutting to limit heat, vibration, and skin injury.
- This is a cast-removal device, not a general-purpose surgical saw; use only with materials and accessories compatible with the device.
- The device is not intended for use inside the body or for cutting bone, soft tissue, or implanted hardware.
- MRI safety should not be assumed. Keep the device and metallic accessories outside the MRI environment unless the manufacturer has provided specific MR safety information.
Frequently Asked Questions
What is the American Orthopaedic Cast Cutter Model 0295-200 used for?
It is used for the safe removal of orthopedic casts in clinical settings.
What specialties typically use this device?
Orthopedic surgeons, emergency room staff, and cast technicians commonly use this device.
What are the FDA-cleared indications?
The device is indicated for the removal of orthopedic casts used in fracture management.
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.