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dbx strip
Musculoskeletal Transplant Foundation
Summary: The dbx strip is a bone graft substitute used in orthopedic surgeries to promote bone healing and regeneration. It is primarily used by orthopedic surgeons and spine specialists.
FDA Clearance Information
Pathway 510K
Number K062205 ↗
Decision Date February 5, 2007
Product Code MBP
Device Class Class 2
Evidence 0 studies
The dbx strip was cleared through the FDA 510(k) pathway on February 5, 2007. It is manufactured by the Musculoskeletal Transplant Foundation and classified as a Class 2 medical device.
What It Is
The dbx strip is a demineralized bone matrix product used as a bone graft substitute. It works by providing a scaffold that supports new bone growth, facilitating the natural bone healing process. This device is particularly useful in situations where bone regeneration is needed, such as in spinal fusions or fracture repairs.
Clinical Applications
The dbx strip is commonly used in orthopedic and spinal surgeries, particularly in procedures requiring bone grafting, such as spinal fusion surgeries. It is suitable for use in both adult and pediatric populations, depending on the specific clinical scenario. The device is typically used in hospital or surgical center settings by orthopedic surgeons and spine specialists.
Indications for Use
The dbx strip is indicated for use in patients requiring bone grafting to promote bone healing and regeneration. It is suitable for conditions such as spinal fusion, fracture repair, and other orthopedic procedures where bone growth is desired.
Practical Considerations
The dbx strip is available in various sizes to accommodate different surgical needs. It is compatible with standard surgical techniques for bone grafting. Surgeons should ensure proper handling and placement to maximize its effectiveness.
Related Literature
The linked study evaluated the efficacy of various bone graft substitutes, including the dbx strip, in an athymic rat model for posterolateral fusion. The study found differences in efficacy among the tested materials, highlighting the importance of selecting the appropriate graft material for clinical use. However, the study's limitations include its animal model and lack of direct clinical data.
Frequently Asked Questions
What is dbx strip used for?
The dbx strip is used as a bone graft substitute to promote bone healing and regeneration in orthopedic surgeries.
What specialties typically use this device?
Orthopedic surgeons and spine specialists typically use the dbx strip in surgical procedures requiring bone grafting.
What are the FDA-cleared indications?
The dbx strip is indicated for use in promoting bone healing and regeneration in procedures such as spinal fusion and fracture repair.
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.