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arthrosurface bone screws
Arthrosurface
Summary: Arthrosurface bone screws are used for fixation in orthopedic surgeries, particularly in glenoid reconstruction. Key evidence highlights their biomechanical efficacy in maintaining stability.
FDA Clearance Information
Pathway
510K
Number
K172383 ↗
Decision Date
December 22, 2017
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 December 22, 2017. Manufactured by Arthrosurface, they are classified as Class 2 devices.
What It Is
Arthrosurface bone screws are orthopedic devices designed for the fixation of bone fragments. 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 shoulder for glenoid reconstruction. They provide stability and support in cases of bone loss or fracture.
Evidence Summary
The available literature includes five studies, ranging from systematic reviews to biomechanical analyses, published between 2016 and 2025. These studies explore various fixation techniques and their biomechanical outcomes.
Reported Outcomes
Published studies report that arthrosurface bone screws provide effective fixation in glenoid reconstruction, with outcomes showing low recurrence and resorption rates. Biomechanical evaluations suggest adequate torque and load to failure, supporting their use in maintaining joint stability.
Safety Profile
Reported complications include potential issues related to screw fixation, such as improper placement or loosening. However, specific adverse events are not detailed in the provided evidence.
Evidence Limitations
The evidence lacks detailed long-term outcomes and specific safety data. Further research is needed to fully understand the biomechanical implications of different fixation techniques and their long-term efficacy.
Frequently Asked Questions
What are the clinical indications for arthrosurface bone screws?
Arthrosurface bone screws are indicated for use in orthopedic surgeries requiring bone fixation, such as glenoid reconstruction in cases of shoulder instability.
What outcomes have been reported in clinical studies?
Studies report effective fixation with low recurrence and resorption rates, supporting their use in maintaining joint stability.
What complications have been reported?
Reported complications include potential issues with screw fixation, such as improper placement or loosening, though specific adverse events are not detailed.
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.