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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 ?
510(k)
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.
FDA-Cleared Indications
- Filling bone voids and defects in orthopedic surgical procedures
- Use in bone defects resulting from trauma or surgical intervention
- Providing support for bone healing and structural support where a bone void is present
Clinical Applications
- Filling bone defects during orthopedic surgery
- Managing bone voids associated with trauma
- Filling defects created during surgical intervention
- Supporting bone healing during procedures such as anterior cruciate ligament reconstruction
- Providing structural support at an orthopedic bone-defect site
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.
Practical Considerations
- The appropriate product size and amount depend on the dimensions and location of the bone defect; the surgeon prepares the site and selects the material accordingly.
- Compatibility with fixation hardware, graft materials, or antibiotic-containing formulations should be confirmed from the specific product labeling.
- MRI safety depends on the composition of the implanted material and any associated hardware; review the exact product labeling before MRI.
- Contraindications and precautions may include active infection, inadequate soft-tissue coverage, allergy to device components, or use outside the labeled orthopedic indications.
- Handling, preparation, implantation, and any cure or setting time must follow the manufacturer's instructions for use.
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.