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optecure
Exactech
Summary: Optecure is a demineralized bone matrix used primarily for bone grafting procedures. It is FDA 510k cleared and supported by studies focusing on ridge augmentation and lumbar spine fusion.
FDA Clearance Information
Pathway
510K
Number
K050806 ↗
Decision Date
February 8, 2006
Product Code
MBP
Device Class
Class 2
Evidence
0 studies
Optecure was cleared by the FDA through the 510k pathway on February 8, 2006. It is manufactured by Exactech and classified as a Class 2 device under product code MBP.
What It Is
Optecure is a demineralized bone matrix designed for use in bone grafting procedures. It serves as an osteoinductive scaffold to facilitate bone regeneration and healing in clinical applications such as spinal fusion and ridge augmentation.
Clinical Applications
Optecure is commonly used in orthopedic and dental surgeries, particularly for procedures requiring bone grafting, such as spinal fusion and ridge augmentation. It is intended to enhance bone regeneration and support structural integrity.
Evidence Summary
The available literature includes three studies, comprising randomized controlled trials and other clinical evaluations. These studies span from 2019 to earlier, focusing on the efficacy of Optecure in bone grafting applications.
Reported Outcomes
Published studies report that Optecure, when used in ridge augmentation and lumbar spine fusion, demonstrates positive clinical and histologic outcomes. The studies highlight its effectiveness in enhancing bone regeneration and structural support.
Safety Profile
Reported complications include typical surgical risks associated with bone grafting procedures. The studies did not specify unique adverse events directly attributable to Optecure.
Evidence Limitations
The evidence is limited by the small number of studies and lack of long-term follow-up data. Further research is needed to confirm the long-term efficacy and safety of Optecure in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Optecure?
Optecure is indicated for use in bone grafting procedures, including spinal fusion and ridge augmentation.
What outcomes have been reported in clinical studies?
Studies report positive outcomes in bone regeneration and structural support in ridge augmentation and spinal fusion.
What complications have been reported?
Reported complications include general surgical risks, with no specific adverse events directly linked to Optecure.
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.