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Optecure Optecure Ccc
Exactech
Summary: Optecure Optecure CCC is a demineralized bone matrix used for bone grafting. It is primarily used in orthopedic procedures for bone augmentation. Key evidence includes studies comparing its efficacy to other graft materials.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K063685 ↗
Decision Date ?
June 7, 2007
Product Code ?
MBP
Device Class ?
Class 2
Evidence ?
0 studies
Optecure Optecure CCC was cleared by the FDA via the 510(k) pathway on June 7, 2007. It is manufactured by Exactech and classified as a Class 2 device under product code MBP.
What It Is
Optecure Optecure CCC is a demineralized bone matrix designed for use in bone grafting procedures. It serves as an osteoinductive scaffold to support new bone growth, commonly used in orthopedic and dental surgeries.
FDA-Cleared Indications
- Use as a bone-graft material to fill bone voids or gaps that are not intrinsic to the stability of the bony structure.
- Use in orthopedic procedures where demineralized bone matrix is intended to support bone formation and bone repair.
- The specific FDA-cleared indication should be confirmed in the device labeling because the available record provides only a summary indication.
Clinical Applications
- Filling contained bone defects or gaps during orthopedic bone-grafting procedures.
- Supporting bone augmentation when additional graft material is needed.
- Use as an osteoinductive scaffold in procedures intended to promote new bone formation.
- Use with other graft materials when permitted by the product labeling and surgical plan.
Reported off-label uses
- Use in dental or oral-maxillofacial bone augmentation, such as ridge preservation or ridge augmentation, when not specifically included in the product labeling.
- Use in selected spinal or fusion procedures when the product labeling does not specifically cover that application.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The available literature includes two studies: one randomized controlled trial and one study with unknown type. These studies focus on the efficacy of Optecure Optecure CCC in bone augmentation, with publication years ranging from 2019 to unknown.
Reported Outcomes
Published studies report that Optecure Optecure CCC is effective in promoting bone growth when used in ridge augmentation procedures. The RCT demonstrated comparable clinical and histologic outcomes to other graft materials, indicating its potential as a viable option for bone augmentation.
Safety Profile
Reported complications include typical surgical risks associated with bone grafting procedures. The studies provided do not detail specific adverse events related to the use of Optecure Optecure CCC.
Evidence Limitations
The evidence is limited by the small number of studies and lack of detailed safety data. Further research is needed to establish long-term outcomes and to compare its efficacy and safety with other bone graft materials.
Practical Considerations
- The available record does not specify the product's particle sizes, dimensions, or packaging configurations; clinicians should consult the current manufacturer instructions for use.
- Handling, hydration, mixing, and placement should follow the product labeling and sterile surgical technique.
- Compatibility with other graft materials, carriers, fixation devices, or biologic products should be confirmed before use.
- MRI safety information is not provided in the available record. Because this is a biologic graft material rather than an implanted metallic device, MRI concerns may relate mainly to any accompanying hardware.
- Contraindications, infection precautions, allergy risks, and restrictions related to pregnancy, malignancy, or impaired healing should be reviewed in the current labeling.
Frequently Asked Questions
What are the clinical indications for Optecure Optecure CCC?
Optecure Optecure CCC is indicated for use in bone grafting procedures, particularly in orthopedic and dental surgeries requiring bone augmentation.
What outcomes have been reported in clinical studies?
Clinical studies have reported that Optecure Optecure CCC is effective in promoting bone growth, with outcomes comparable to other graft materials in ridge augmentation procedures.
What complications have been reported?
Reported complications include general surgical risks, but specific adverse events related to Optecure Optecure CCC were not detailed in the provided studies.
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.