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dbx demineralized bone matrix mix
Musculoskeletal Transplant Foundation
Summary: The dbx demineralized bone matrix mix is a bone graft substitute used primarily in orthopedic procedures. It is FDA-cleared and has been studied in various clinical settings, though evidence on efficacy and safety is limited.
FDA Clearance Information
Pathway
510K
Number
K063676 ↗
Decision Date
March 5, 2007
Product Code
MBP
Device Class
Class 2
Evidence
0 studies
The dbx demineralized bone matrix mix was cleared by the FDA via the 510(k) pathway on March 5, 2007. It is manufactured by the Musculoskeletal Transplant Foundation and is classified as a Class 2 medical device.
What It Is
The dbx demineralized bone matrix mix is a bone graft substitute designed to aid in bone regeneration and healing. It is used in orthopedic and spinal surgeries to support bone growth and fusion.
Clinical Applications
This device is commonly used in spinal fusion surgeries and other orthopedic procedures where bone grafting is necessary. It provides a scaffold for new bone growth and is often used in conjunction with autograft materials.
Evidence Summary
The available literature includes three studies, with a mix of prospective and unknown study types. The studies range from 2022 to earlier, focusing on the efficacy of bone graft substitutes.
Reported Outcomes
Published studies report varying efficacy of the dbx demineralized bone matrix mix compared to other bone graft substitutes. One study in an animal model highlighted differences in efficacy among various materials, but specific outcomes for dbx were not detailed.
Safety Profile
Reported complications include limited data on adverse events specific to the dbx demineralized bone matrix mix. The studies reviewed did not provide detailed safety outcomes.
Evidence Limitations
The evidence base for the dbx demineralized bone matrix mix is limited, with few studies providing detailed efficacy or safety data. Further research is needed to establish comprehensive clinical outcomes and safety profiles.
Frequently Asked Questions
What are the clinical indications for dbx demineralized bone matrix mix?
The dbx demineralized bone matrix mix is indicated for use in orthopedic and spinal surgeries to support bone growth and fusion.
What outcomes have been reported in clinical studies?
Studies have reported varying efficacy of the dbx mix compared to other substitutes, but specific outcomes are not detailed.
What complications have been reported?
Limited data on adverse events specific to the dbx mix is available, with no detailed safety outcomes reported.
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.