📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use as a bone graft substitute to aid the repair or regeneration of bone tissue.
- Use in orthopedic procedures when a bone defect requires graft material.
Clinical Applications
- Filling bone defects during spinal fusion procedures
- Supporting repair of bone defects associated with fractures
- Filling bone defects during joint reconstruction
- Use with standard orthopedic fixation techniques when additional graft material is needed
Practical Considerations
- The product is available in different sizes or configurations; the surgeon selects the appropriate amount for the defect and procedure.
- It may be used with standard orthopedic surgical techniques and fixation devices, but compatibility should be confirmed before use.
- The graft must be handled according to the manufacturer’s instructions to preserve its structural and biologic properties.
- MRI safety depends on the final implanted construct and any fixation hardware used with the graft; the product labeling and the implanting surgeon should be consulted.
- Contraindications, precautions, infection risk, and suitability for a specific patient should be reviewed in the current labeling and by the treating orthopedic surgeon.
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.