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dbx strip
Musculoskeletal Transplant Foundation
Summary: The dbx strip is a bone graft substitute used primarily in orthopedic and spinal surgeries to promote bone healing and fusion. It is typically used by orthopedic surgeons and neurosurgeons.
FDA Clearance Information
Pathway
510K
Number
K042829 ↗
Decision Date
January 13, 2006
Product Code
MBP
Device Class
Class 2
Evidence
0 studies
The dbx strip was cleared through the FDA 510(k) pathway on January 13, 2006. It is manufactured by the Musculoskeletal Transplant Foundation and classified as a Class 2 device under product code MBP.
What It Is
The dbx strip is a demineralized bone matrix product used as a bone graft substitute. It is designed to support bone regeneration by providing a scaffold that facilitates the growth of new bone tissue. The device is typically used in surgical procedures where bone healing is required, such as spinal fusions or fracture repairs.
Clinical Applications
The dbx strip is commonly used in orthopedic and neurosurgical procedures, particularly in spinal fusion surgeries. It is suitable for patients requiring bone grafting to enhance bone healing, such as those with spinal degenerative conditions or fractures. The device is used in hospital operating rooms and surgical centers, primarily by orthopedic surgeons and neurosurgeons.
Indications for Use
The dbx strip is indicated for use in patients who need bone grafting to promote bone healing and fusion. It is suitable for conditions like spinal degenerative diseases or fractures where bone regeneration is necessary.
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 and can be used in conjunction with other graft materials if needed. Surgeons should consider the specific anatomical and clinical requirements of each patient when selecting the appropriate size and application method.
Related Literature
The linked study compared the efficacy of various human bone graft substitutes in an athymic rat model for posterolateral fusion. It highlighted differences in efficacy among commercially available materials, noting that many lack clinical data. The study provides valuable insights into the performance of these materials, although its findings are limited by the use of an animal model, which may not fully translate to human clinical outcomes.
Frequently Asked Questions
What is dbx strip used for?
The dbx strip is used as a bone graft substitute to promote bone healing and fusion, particularly in orthopedic and spinal surgeries.
What specialties typically use this device?
Orthopedic surgeons and neurosurgeons typically use the dbx strip, especially in procedures involving spinal fusion and bone grafting.
What are the FDA-cleared indications?
The dbx strip is indicated for use in patients requiring bone grafting to support bone healing and fusion, such as in spinal degenerative conditions or fractures.
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.