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osteoset dbm pellets
Wrightmedicaltechnology
Summary: Osteoset DBM Pellets are used for bone regeneration. They are primarily indicated for filling bone defects. Key evidence shows efficacy in defect healing.
FDA Clearance Information
Pathway
510K
Number
K053642 ↗
Decision Date
January 26, 2006
Product Code
MBP
Device Class
Class 2
Evidence
0 studies
The Osteoset DBM Pellets were cleared by the FDA via the 510(k) pathway on January 26, 2006. Manufactured by Wrightmedicaltechnology, they are classified as Class 2 under product code MBP.
What It Is
Osteoset DBM Pellets are a combination of calcium sulfate and demineralized bone matrix. They are designed to aid in bone regeneration by filling bone defects and providing a scaffold for new bone growth.
Clinical Applications
Commonly used in orthopedic and reconstructive surgeries, Osteoset DBM Pellets are applied to fill bone voids or defects that are not intrinsic to the stability of the bony structure.
Evidence Summary
The available literature includes two studies from 2002 and 2004. These studies are primarily prospective and retrospective in nature, focusing on the efficacy of Osteoset DBM Pellets in bone defect healing.
Reported Outcomes
Published studies report that Osteoset DBM Pellets are effective in promoting bone healing in large defects. The studies highlight successful bone regeneration in both animal models and clinical scenarios, demonstrating the pellets' ability to integrate with host bone tissue.
Safety Profile
Reported complications include minimal adverse events, with studies indicating a favorable safety profile. No significant complications were noted in the reviewed literature.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to confirm long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Osteoset DBM Pellets?
Osteoset DBM Pellets are indicated for filling bone voids or defects that are not intrinsic to the stability of the bony structure.
What outcomes have been reported in clinical studies?
Studies have reported successful bone regeneration and defect healing with the use of Osteoset DBM Pellets.
What complications have been reported?
The reviewed studies reported minimal adverse events, indicating a favorable safety profile for Osteoset DBM Pellets.
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.