đź“‹ FDA Reference
progenix dbm putty and paste
Medtronic Sofamor Danek
Summary: Progenix DBM Putty and Paste 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 K060794 ↗
Decision Date December 18, 2006
Product Code MBP
Device Class Class 2
Evidence 0 studies
Progenix DBM Putty and Paste was cleared through the FDA 510(k) pathway on December 18, 2006. It is manufactured by Medtronic Sofamor Danek and classified as a Class II medical device.
What It Is
Progenix DBM Putty and Paste is a demineralized bone matrix (DBM) product used as a bone graft substitute. It is designed to facilitate bone growth and healing by providing a scaffold that supports the proliferation of osteogenic cells. The putty and paste formulations allow for easy handling and application during surgical procedures.
Clinical Applications
This device is commonly used in orthopedic and spinal surgeries, particularly in procedures requiring bone grafting, such as spinal fusions and fracture repairs. It is suitable for use in both inpatient and outpatient settings and is often applied in adult and pediatric populations requiring bone regeneration.
Indications for Use
The FDA indications for Progenix DBM Putty and Paste include its use as a bone graft substitute in orthopedic and spinal surgeries. It is intended for patients needing bone regeneration, such as those undergoing spinal fusion or fracture repair.
Practical Considerations
Progenix DBM Putty and Paste is available in various sizes to accommodate different surgical needs. It is compatible with standard surgical techniques and can be molded to fit the defect site. Surgeons should ensure proper handling to maintain sterility and effectiveness.
Frequently Asked Questions
What is Progenix DBM Putty and Paste used for?
Progenix DBM Putty and Paste is used as a bone graft substitute in orthopedic and spinal surgeries to promote bone growth and healing.
What specialties typically use this device?
Orthopedic surgeons and neurosurgeons commonly use this device in their surgical procedures.
What are the FDA-cleared indications?
The FDA-cleared indications include its use as a bone graft substitute in orthopedic and spinal surgeries for patients requiring bone regeneration.
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.