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interface bone void filler
Biostructures
Summary: The interface bone void filler by Biostructures is a device used to fill bone voids. It is primarily used in orthopedic surgeries to support bone healing. Key evidence highlights its role in improving fixation and controlling antibiotic release.
FDA Clearance Information
Pathway
510K
Number
K112857 ↗
Decision Date
December 13, 2011
Product Code
MQV
Device Class
Class 2
Evidence
0 studies
The interface bone void filler was cleared by the FDA through the 510(k) pathway on December 13, 2011. It is manufactured by Biostructures and classified as a Class 2 device under product code MQV.
What It Is
The interface bone void filler is a medical device designed to fill bone voids and defects. It is used in orthopedic surgeries to aid in bone healing and provide structural support. The device is intended for use in scenarios where bone defects are present due to trauma or surgical intervention.
Clinical Applications
Common clinical scenarios for the interface bone void filler include orthopedic surgeries such as anterior cruciate ligament reconstruction and procedures requiring bone defect management. It is particularly useful in cases where bone healing needs to be facilitated or where structural support is required.
Evidence Summary
The available literature includes 10 studies, encompassing various study types such as RCTs and case series, with publication years ranging from 2020 to 2024. These studies explore the device's efficacy and safety in different clinical contexts.
Reported Outcomes
Published studies report that the interface bone void filler effectively supports bone healing and fixation in orthopedic surgeries. It has been shown to improve the interface between bone and implants, enhancing biological activity and bone ingrowth. Additionally, it aids in controlling antibiotic release in bone cement applications.
Safety Profile
Reported complications include potential tissue toxicity associated with high antibiotic concentrations in antibiotic-loaded bone cements. However, the device's formulation aims to mitigate such risks by controlling antibiotic release.
Evidence Limitations
Current evidence is limited by the lack of long-term follow-up studies and direct comparisons with alternative fixation methods. Further research is needed to explore the device's long-term efficacy and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for interface bone void filler?
The interface bone void filler is indicated for use in filling bone voids and defects in orthopedic surgeries, particularly where bone healing and structural support are required.
What outcomes have been reported in clinical studies?
Clinical studies have reported improved bone healing, fixation, and controlled antibiotic release, enhancing the interface between bone and implants.
What complications have been reported?
Reported complications include tissue toxicity from high antibiotic concentrations, though the device aims to control antibiotic release to minimize this risk.
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.