đź“Š Evidence-Based Reference
arthrosurface bone screws
Arthrosurface
Summary: Arthrosurface bone screws are used for fixation in orthopedic procedures, particularly in glenoid reconstruction. Key evidence highlights their biomechanical efficacy in maintaining stability.
FDA Clearance Information
Pathway
510K
Number
K161539 ↗
Decision Date
June 30, 2016
Product Code
HWC
Device Class
Class 2
Evidence
0 studies
The Arthrosurface bone screws were cleared by the FDA via the 510(k) pathway on June 30, 2016. Manufactured by Arthrosurface, they are classified as Class 2 devices.
What It Is
Arthrosurface bone screws are orthopedic fixation devices designed to secure bone grafts or fragments in place. They are primarily used in procedures requiring stable fixation, such as glenoid reconstruction in shoulder surgeries.
Clinical Applications
These screws are commonly used in orthopedic surgeries involving bone graft fixation, particularly in the context of glenoid reconstruction for shoulder instability. They provide mechanical stability to ensure proper healing and integration of grafts.
Evidence Summary
The literature includes five studies, covering various aspects of bone screw fixation, with publication years ranging from 2016 to 2025. Study types include systematic reviews and biomechanical analyses.
Reported Outcomes
Published studies report that Arthrosurface bone screws provide effective fixation in glenoid reconstruction, with outcomes indicating low recurrence and resorption rates. Biomechanical evaluations suggest adequate torque and load-bearing capacity, contributing to successful surgical outcomes.
Safety Profile
Reported complications include potential issues with screw insertion torque and load to failure, although specific adverse events are not detailed in the available studies. Overall, the safety profile appears favorable with proper surgical technique.
Evidence Limitations
The evidence is limited by a lack of large-scale randomized controlled trials and long-term follow-up data. Further research is needed to fully understand the biomechanical implications and long-term outcomes of using these screws in various orthopedic procedures.
Frequently Asked Questions
What are the clinical indications for Arthrosurface bone screws?
Arthrosurface bone screws are indicated for use in orthopedic procedures requiring bone fixation, such as glenoid reconstruction in shoulder instability cases.
What outcomes have been reported in clinical studies?
Clinical studies report effective fixation with low recurrence and resorption rates, as well as adequate biomechanical performance in terms of torque and load-bearing capacity.
What complications have been reported?
Reported complications include potential issues with screw insertion torque and load to failure, though specific adverse events are not detailed in the studies.
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.