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Cleared Under Grafton II Edbm
Summary: Grafton II eDBM is a demineralized bone matrix used in orthopedic and spinal surgeries to promote bone growth. It is typically used by orthopedic surgeons and neurosurgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K122513 ↗
Decision Date ?
March 6, 2013
Product Code ?
MBP
Device Class ?
Class 2
Evidence ?
0 studies
Grafton II eDBM was cleared through the FDA 510(k) pathway on March 6, 2013. Manufactured by Medtronic Sofamor Danek, it is classified as a Class 2 device under product code MBP.
What It Is
Grafton II eDBM is a bone graft substitute composed of demineralized bone matrix. It is designed to facilitate bone regeneration and healing by providing a scaffold for new bone growth. The device is typically used in conjunction with other graft materials to enhance the biological environment for bone repair.
FDA-Cleared Indications
- Use as a bone-graft substitute in orthopedic surgical procedures where bone repair or fusion is required.
- Use to provide a framework that supports new bone formation at a surgical site.
- Use alone or with other graft materials, according to the product labeling and surgical technique.
Clinical Applications
- Supplementing bone graft during spinal fusion procedures.
- Filling or augmenting bone defects created during orthopedic surgery.
- Supporting bone healing during fracture-repair procedures when a graft substitute is indicated.
- Providing demineralized bone matrix material for reconstructive orthopedic procedures.
Practical Considerations
- The product may be supplied in different forms, such as putty or gel, and the selected form should match the surgical site and handling requirements.
- It may be used with autograft, allograft, or other graft materials when appropriate for the procedure.
- Because it is derived from human bone tissue, clinicians should review donor screening, processing, storage, and tissue-bank information before use.
- MRI safety information should be confirmed in the current product labeling; MRI conditions may differ by product configuration and packaging.
- Contraindications, precautions, handling, and reconstitution requirements should be taken from the current manufacturer instructions for use.
Frequently Asked Questions
What is Grafton II eDBM used for?
Grafton II eDBM is used as a bone graft substitute to promote bone healing and regeneration in orthopedic and spinal surgeries.
What specialties typically use this device?
Orthopedic surgeons and neurosurgeons commonly use Grafton II eDBM in surgical settings.
What are the FDA-cleared indications?
Grafton II eDBM is indicated for use as a bone graft substitute in orthopedic procedures requiring bone repair or augmentation.
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.