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conventus orthopaedics fracture fixation system
Conventus Orthopaedics
Summary: The Conventus Orthopaedics Fracture Fixation System is a device designed for fracture stabilization. It is primarily used in orthopedic surgeries for fracture fixation. Key evidence includes biomechanical evaluations and anatomical studies.
FDA Clearance Information
Pathway
510K
Number
K102689 ↗
Decision Date
January 17, 2013
Product Code
HRS
Device Class
Class 2
Evidence
0 studies
The Conventus Orthopaedics Fracture Fixation System was cleared via the FDA 510(k) pathway on January 17, 2013. It is manufactured by Conventus Orthopaedics and classified as a Class 2 device under product code HRS.
What It Is
The Conventus Orthopaedics Fracture Fixation System is a medical device used for the stabilization of fractures. It operates as an intramedullary fixation scaffold, providing support to fractured bones. It is intended for use in orthopedic surgical procedures.
Clinical Applications
This device is commonly used in clinical scenarios involving fractures of the femoral neck, distal radius, and proximal humerus. It is applied in minimally invasive procedures to stabilize bone fractures and promote healing.
Evidence Summary
The available literature includes five studies, comprising biomechanical evaluations and anatomical analyses. These studies span from 2019 to 2025, providing insights into the device's performance and application.
Reported Outcomes
Published studies report that the Conventus Orthopaedics Fracture Fixation System demonstrates effective stabilization in synthetic bone models for femoral neck fractures. Outcomes from distal radius fixation using the device indicate successful fracture management in a series of patients.
Safety Profile
Reported complications include potential risks associated with the minimally invasive nature of the device's application, particularly in the distal radius. No specific adverse events were detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small sample sizes and the lack of long-term outcome data. Further research is needed to evaluate the device's efficacy in diverse patient populations and to assess long-term safety and functional outcomes.
Frequently Asked Questions
What are the clinical indications for Conventus Orthopaedics Fracture Fixation System?
The device is indicated for the stabilization of fractures, particularly in the femoral neck, distal radius, and proximal humerus.
What outcomes have been reported in clinical studies?
Studies report effective stabilization of fractures, with successful management of distal radius fractures in a series of patients.
What complications have been reported?
Safety data indicate potential risks related to the minimally invasive application, but specific adverse events were 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.