đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use as a bone graft substitute in orthopedic surgical procedures where bone healing or regeneration is desired.
- Use to support bone growth in procedures such as spinal fusion and fracture repair, when selected by the treating surgeon.
Clinical Applications
- Bone grafting during spinal fusion procedures
- Bone grafting during repair of fractures or bone defects
- Orthopedic surgery requiring a demineralized bone matrix scaffold
- Supporting bone healing and regeneration when used with standard surgical techniques
Practical Considerations
- The strip is available in different sizes; the surgeon selects the size and amount based on the defect and procedure.
- It is implanted using standard bone-grafting techniques and must be handled and placed according to the product labeling.
- As a human tissue-derived product, patient screening, storage, preparation and sterile handling requirements apply.
- MRI safety depends on the implanted material and any fixation hardware used during the procedure; patients should provide the implant information to the MRI facility.
- Contraindications, warnings and precautions in the current product labeling should be reviewed, including factors that may impair healing or increase infection risk.
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.