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cleared under grafton ii edbm
Medtronic Sofamor Danek
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
510K
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.
Clinical Applications
Grafton II eDBM is commonly used in orthopedic and spinal surgeries, such as spinal fusion and fracture repair. It is particularly useful in cases where bone healing is critical, such as in patients with compromised bone health or in complex reconstructive procedures. The device is used in hospital settings by orthopedic surgeons and neurosurgeons.
Indications for Use
The FDA-cleared indications for Grafton II eDBM include its use as a bone graft substitute in orthopedic procedures. It is intended for patients requiring bone repair or augmentation, such as those undergoing spinal fusion or fracture treatment.
Practical Considerations
Grafton II eDBM is available in various forms, including putty and gel, allowing for flexibility in surgical application. It is compatible with other graft materials and can be used in a variety of surgical techniques. Clinicians should consider the specific surgical requirements and patient needs when selecting the appropriate form and application method.
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.