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Musculoskeletal Transplant Foundation
Summary: The dbx demineralized bone matrix is a bone graft substitute used primarily in spinal fusion surgeries. Key evidence suggests its efficacy in promoting bone healing, though comparative data is limited.
FDA Clearance Information
Pathway
510K
Number
K080399 ↗
Decision Date
October 10, 2008
Product Code
MBP
Device Class
Class 2
Evidence
0 studies
The dbx demineralized bone matrix was cleared by the FDA through the 510(k) pathway on October 10, 2008. It is manufactured by the Musculoskeletal Transplant Foundation and classified as a Class 2 device.
What It Is
The dbx demineralized bone matrix is a bone graft substitute composed of demineralized bone particles in a carrier, designed to enhance bone healing and fusion. It is primarily used in orthopedic and spinal surgeries.
Clinical Applications
Commonly used in spinal fusion procedures, the dbx demineralized bone matrix aids in bone regeneration and healing. It is particularly utilized in cases where autograft material is insufficient or not available.
Evidence Summary
The available literature includes 12 studies, comprising prospective and retrospective analyses, with a focus on the efficacy of demineralized bone matrix in bone healing. The studies span from 2010 to 2022.
Reported Outcomes
Published studies report that the dbx demineralized bone matrix is effective in promoting bone healing and fusion in spinal surgeries. Comparative studies indicate variability in efficacy among different bone graft substitutes, with dbx showing promising results in specific models.
Safety Profile
Reported complications include potential dilution of osteoinductive components due to the carrier used in the matrix. However, specific adverse events related to dbx were not detailed in the provided studies.
Evidence Limitations
The evidence is limited by a lack of large-scale clinical trials directly comparing dbx to other bone graft substitutes. Further research is needed to establish long-term outcomes and safety profiles.
Frequently Asked Questions
What are the clinical indications for dbx demineralized bone matrix?
The dbx demineralized bone matrix is indicated for use in spinal fusion surgeries and other orthopedic procedures requiring bone grafting.
What outcomes have been reported in clinical studies?
Studies have reported effective bone healing and fusion in spinal surgeries using dbx, with some variability in efficacy compared to other substitutes.
What complications have been reported?
Reported complications include potential dilution of osteoinductive components due to the carrier, but specific adverse events were not detailed.
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.