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conventus orthopaedics ulna fixation system
Conventus Orthopaedics
Summary: The Conventus Orthopaedics Ulna Fixation System is a medical device used for stabilizing ulna fractures. It is primarily used by orthopedic surgeons to treat patients with ulna injuries.
FDA Clearance Information
Pathway
510K
Number
K161048 ↗
Decision Date
July 26, 2016
Product Code
HRS
Device Class
Class 2
Evidence
0 studies
The Conventus Orthopaedics Ulna Fixation System was cleared through the FDA 510k pathway on July 26, 2016. It is manufactured by Conventus Orthopaedics and classified as a Class 2 device under the product code HRS.
What It Is
The Conventus Orthopaedics Ulna Fixation System is designed to provide internal fixation for ulna fractures. It typically consists of a series of plates and screws that stabilize the bone, allowing for proper healing. This system is particularly useful in cases where traditional casting or external fixation is insufficient.
Clinical Applications
This device is commonly used in orthopedic surgery, particularly in trauma settings where ulna fractures are prevalent. It is suitable for both acute fractures and non-unions in adults. Orthopedic surgeons use this system in hospital operating rooms or specialized orthopedic centers.
Indications for Use
The FDA-cleared indications for this device include the treatment of ulna fractures. It is intended for patients who have sustained fractures to the ulna bone, either due to trauma or other causes.
Practical Considerations
The system comes in various sizes to accommodate different patient anatomies and fracture types. Surgeons should be familiar with the specific surgical techniques required for proper placement and fixation. Compatibility with other orthopedic systems should be verified prior to use.
Frequently Asked Questions
What is the Conventus Orthopaedics Ulna Fixation System used for?
It is used for stabilizing and fixing ulna fractures to promote proper bone healing.
What specialties typically use this device?
Orthopedic surgeons, particularly those specializing in trauma and fracture management, commonly use this device.
What are the FDA-cleared indications?
The device is indicated for the treatment of ulna fractures, including those resulting from trauma.
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.