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viagraf dbm paste
Osteotech
Summary: Viagraf DBM Paste is a demineralized bone matrix used in orthopedic surgeries to promote bone healing. Key evidence highlights its use in bone fusion and tendon repair.
FDA Clearance Information
Pathway
510K
Number
K043209 ↗
Decision Date
December 5, 2005
Product Code
MBP
Device Class
Class 2
Evidence
0 studies
Viagraf DBM Paste was cleared through the FDA 510(k) pathway on December 5, 2005. It is manufactured by Osteotech and classified as a Class 2 medical device.
What It Is
Viagraf DBM Paste is a demineralized bone matrix used to enhance bone healing and regeneration. It is intended for use in orthopedic procedures to support bone fusion and repair.
Clinical Applications
Commonly used in orthopedic surgeries, Viagraf DBM Paste is applied in scenarios such as spinal fusion, bone defect repair, and tendon-bone healing. It serves as an alternative to autologous bone grafts.
Evidence Summary
The literature includes 10 studies, comprising randomized controlled trials, prospective and retrospective studies, and case series, published between 2020 and 2024.
Reported Outcomes
Published studies report that Viagraf DBM Paste is effective in promoting bone fusion and enhancing osteointegration in orthopedic surgeries. It has shown promise in tendon-bone healing and as an adjunct in revision arthroplasty.
Safety Profile
Reported complications include potential for infection and inflammatory response at the application site. Overall, the safety profile is consistent with other bone graft substitutes.
Evidence Limitations
Current evidence is limited by small sample sizes and variability in study design. Further research is needed to establish optimal dosing and long-term outcomes.
Frequently Asked Questions
What are the clinical indications for Viagraf DBM Paste?
Viagraf DBM Paste is indicated for use in bone fusion, repair of bone defects, and tendon-bone healing in orthopedic surgeries.
What outcomes have been reported in clinical studies?
Studies report successful bone fusion and enhanced osteointegration, with positive outcomes in tendon-bone healing and revision arthroplasty.
What complications have been reported?
Reported complications include infection and inflammatory response, consistent with other bone graft substitutes.
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.