đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Internal fixation of ulna fractures.
Clinical Applications
- Surgical stabilization of acute ulna fractures.
- Fixation of ulna fracture fragments using orthopedic implants such as plates and screws.
- Treatment of ulna fractures when casting or other nonsurgical stabilization is not appropriate.
Practical Considerations
- The system is available in different implant sizes and configurations; the surgeon selects components based on the patient's anatomy and fracture pattern.
- Implant placement requires appropriate surgical exposure, reduction of the fracture, and imaging or direct visualization to confirm alignment and fixation.
- Compatibility with other fixation systems should be confirmed before combining implants from different systems.
- MRI safety and conditions depend on the specific implant materials and labeling; the operative implant record and current manufacturer instructions should be reviewed before MRI.
- Implant removal, additional surgery, or treatment of complications may be needed if healing is incomplete, the implant becomes painful or prominent, or infection or hardware failure occurs.
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.