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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 ?
510(k)
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.
FDA-Cleared Indications
- Use as a bone graft substitute or bone void filler in orthopedic procedures where bone graft material is needed.
- Use to support bone formation and healing in areas with bone defects or gaps that are not intrinsic to the stability of the bony structure.
- Use in spinal fusion procedures as part of the graft material selected by the treating surgeon.
Clinical Applications
- Filling contained bone defects or gaps created during orthopedic surgery.
- Supporting bone fusion procedures, including selected spinal fusion procedures.
- Providing a graft substitute when autologous bone graft is unavailable, insufficient, or not preferred.
- Supporting healing where demineralized bone matrix is used with other graft materials or fixation.
Reported off-label uses
- Use in selected tendon-to-bone repair procedures as an adjunct to healing.
- Use in revision bone-grafting procedures or difficult-to-heal fusion sites.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- The paste is handled and placed directly into the prepared bone defect or fusion site; the surgeon determines the amount required.
- It may be used alone or combined with autologous bone, allograft, or other graft materials when compatible with the procedure.
- It is a human tissue-derived product and should be used according to tissue-bank processing, storage, preparation, and handling instructions.
- Contraindications and precautions may include active infection, inadequate soft-tissue coverage, insufficient blood supply, allergy or sensitivity to processing components, and conditions that impair bone healing.
- MRI safety depends on any separate implant or carrier used with the graft; the demineralized bone matrix itself is not a metallic implant, but the complete surgical construct should be reviewed.
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.