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optium dbm gel and putty
Lifenet
Summary: The Optium DBM Gel and Putty by Lifenet is a bone graft substitute 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
K053098 ↗
Decision Date
November 28, 2005
Product Code
MBP
Device Class
Class 2
Evidence
0 studies
The Optium DBM Gel and Putty was cleared via the FDA 510(k) pathway on November 28, 2005. Manufactured by Lifenet, it is classified as a Class II medical device.
What It Is
The Optium DBM Gel and Putty is a demineralized bone matrix (DBM) product used as a bone graft substitute. It is composed of processed human bone tissue that has been demineralized to expose proteins that aid in bone regeneration. The gel and putty forms allow for easy handling and application during surgical procedures. This device is designed to support bone healing and growth by providing a scaffold for new bone formation.
Clinical Applications
This device is commonly used in orthopedic and spinal surgeries, particularly in procedures requiring bone grafting, such as spinal fusions, fracture repair, and reconstructive surgeries. It is suitable for use in both adult and pediatric populations, depending on the specific clinical scenario. The gel and putty forms are advantageous in minimally invasive procedures due to their ease of application and adaptability to different surgical sites.
Indications for Use
The Optium DBM Gel and Putty is indicated for use in patients requiring bone grafting to promote bone growth and healing. It is suitable for conditions such as spinal fusions, bone defects, and non-unions where enhanced bone regeneration is desired.
Practical Considerations
The Optium DBM Gel and Putty is available in various sizes to accommodate different surgical needs. It is compatible with standard surgical instruments and techniques. Surgeons should ensure proper handling to maintain sterility and effectiveness during application.
Frequently Asked Questions
What is Optium DBM Gel and Putty used for?
It is used as a bone graft substitute to promote bone growth in orthopedic and spinal surgeries.
What specialties typically use this device?
Orthopedic surgeons and neurosurgeons commonly use this device in surgical procedures.
What are the FDA-cleared indications?
It is indicated for use in bone grafting procedures to support bone growth and healing in conditions like spinal fusions and bone defects.
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.