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optecure ccc
Exactech
Summary: Optecure CCC is a bone graft substitute used in orthopedic surgeries for bone repair and regeneration. It is primarily used by orthopedic surgeons in various clinical settings.
FDA Clearance Information
Pathway 510K
Number K061668 ↗
Decision Date September 12, 2006
Product Code MBP
Device Class Class 2
Evidence 0 studies
Optecure CCC, manufactured by Exactech, was cleared through the FDA 510k pathway on September 12, 2006. It is classified as a Class 2 device under product code MBP.
What It Is
Optecure CCC is a composite bone graft substitute that combines demineralized bone matrix with a carrier to facilitate bone growth and healing. It is designed to be used in orthopedic procedures to repair or regenerate bone tissue. The device provides a scaffold for new bone growth, enhancing the body's natural healing process.
Clinical Applications
Optecure CCC is commonly used in orthopedic surgeries such as spinal fusion, fracture repair, and joint reconstruction. It is particularly valuable in settings where bone defects need to be filled or where bone regeneration is necessary. The device is suitable for use in adult patients requiring bone grafting procedures.
Indications for Use
Optecure CCC is indicated for use in patients who require bone grafting to aid in the repair or regeneration of bone tissue. This includes conditions such as spinal fusion, fracture repair, and other orthopedic procedures where bone defects are present.
Practical Considerations
Optecure CCC is available in various sizes to accommodate different surgical needs. It is compatible with standard orthopedic surgical techniques and can be used in conjunction with other fixation devices. Surgeons should ensure proper handling to maintain the integrity of the graft material.
Related Literature
The linked study compared the efficacy of a block allograft to a demineralized bone matrix allograft for ridge augmentation. Although the abstract is not available, such studies typically evaluate the effectiveness of different bone graft materials in promoting bone growth. Limitations may include sample size and lack of long-term follow-up data.
Frequently Asked Questions
What is Optecure CCC used for?
Optecure CCC is used for bone repair and regeneration in orthopedic surgeries.
What specialties typically use this device?
Orthopedic surgeons commonly use Optecure CCC in procedures requiring bone grafting.
What are the FDA-cleared indications?
Optecure CCC is indicated for use in bone grafting procedures to aid in bone repair and regeneration.
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.