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grafton plus dbm paste
Osteotech
Summary: Grafton Plus DBM Paste 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
K043048 ↗
Decision Date
November 23, 2005
Product Code
MBP
Device Class
Class 2
Evidence
0 studies
Grafton Plus DBM Paste was cleared through the FDA 510(k) pathway on November 23, 2005. It is manufactured by Osteotech and classified as a Class 2 medical device.
What It Is
Grafton Plus DBM Paste is a demineralized bone matrix product that serves as a bone graft substitute. It is designed to facilitate bone growth and healing by providing a scaffold that supports the infiltration of osteogenic cells and the deposition of new bone. The paste form allows for easy application and molding to the defect site, making it versatile for various surgical settings.
Clinical Applications
This device is commonly used in orthopedic and spinal surgeries, such as spinal fusion, fracture repair, and reconstructive procedures. It is particularly beneficial in cases where autograft bone is limited or undesirable. The paste is suitable for use in both adult and pediatric populations, and it is typically applied in hospital or surgical center settings.
Indications for Use
The FDA-cleared indications for Grafton Plus DBM Paste include its use as a bone graft extender or substitute in orthopedic procedures. It is intended for patients requiring bone growth stimulation, such as those undergoing spinal fusion or fracture repair.
Practical Considerations
Grafton Plus DBM Paste is available in various sizes to accommodate different surgical needs. It is compatible with standard surgical techniques and instruments. Surgeons should ensure proper handling to maintain sterility and efficacy during application.
Frequently Asked Questions
What is Grafton Plus DBM Paste used for?
Grafton Plus DBM Paste is used to promote bone growth in orthopedic and spinal surgeries, serving as a bone graft substitute.
What specialties typically use this device?
Orthopedic surgeons and neurosurgeons typically use this device in procedures involving bone repair and regeneration.
What are the FDA-cleared indications?
The FDA-cleared indications include its use as a bone graft extender or substitute in orthopedic procedures requiring bone growth stimulation.
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.