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grafton dbm
Osteotech
Summary: Grafton DBM is a demineralized bone matrix used primarily in orthopedic and trauma surgeries. Key evidence highlights its application in spinal fusion and cleft reconstruction.
FDA Clearance Information
Pathway
510K
Number
K051195 ↗
Decision Date
December 16, 2005
Product Code
MBP
Device Class
Class 2
Evidence
0 studies
Grafton DBM was cleared through the FDA 510(k) pathway on December 16, 2005. It is manufactured by Osteotech and classified as a Class 2 medical device.
What It Is
Grafton DBM is a demineralized bone matrix designed to promote bone healing and regeneration. It is used in various orthopedic procedures to enhance bone grafting and fusion.
Clinical Applications
Commonly used in spinal fusion surgeries and reconstruction of bony defects, Grafton DBM serves as an osteoconductive scaffold facilitating bone growth and healing.
Evidence Summary
The literature includes 15 studies, comprising RCTs, prospective, and retrospective analyses, published between 2017 and 2021. These studies evaluate the efficacy and safety of Grafton DBM in orthopedic applications.
Reported Outcomes
Published studies report that Grafton DBM is effective in promoting bone fusion in spinal surgeries and cleft reconstructions. It has shown comparable outcomes to autologous bone grafts in certain contexts.
Safety Profile
Reported complications include donor site morbidity and a potential failure rate of up to 20% in cleft reconstructions. However, specific adverse events related to Grafton DBM itself are not extensively detailed in the studies.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of large-scale RCTs. Further research is needed to establish long-term outcomes and safety profiles in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Grafton DBM?
Grafton DBM is indicated for use in spinal fusion surgeries and reconstruction of bony defects, such as in cleft palate repair.
What outcomes have been reported in clinical studies?
Studies have reported effective bone fusion and comparable outcomes to autologous bone grafts in spinal and cleft reconstruction surgeries.
What complications have been reported?
Safety data indicate potential donor site morbidity and a failure rate of up to 20% in certain reconstructions, though specific device-related adverse events are not well-documented.
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.