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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 510K
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.
Clinical Applications
This device is commonly used in clinical scenarios requiring bone augmentation, such as ridge augmentation in dental procedures and other orthopedic applications where bone regeneration is needed.
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.
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.