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avanti orthopaedics ulnar shortening system
Avanti Orthopaedics
Summary: The Avanti Orthopaedics Ulnar Shortening System is a surgical device used to treat ulnar impaction syndrome. It is primarily used by orthopedic surgeons in procedures to shorten the ulna and relieve wrist pain.
FDA Clearance Information
Pathway
510K
Number
K211592 ↗
Decision Date
July 16, 2021
Product Code
HRS
Device Class
Class 2
Evidence
0 studies
The Avanti Orthopaedics Ulnar Shortening System was cleared through the FDA 510k pathway on July 16, 2021. Manufactured by Avanti Orthopaedics, it is classified as a Class 2 medical device.
What It Is
The Avanti Orthopaedics Ulnar Shortening System is designed to surgically shorten the ulna, a bone in the forearm, to alleviate conditions such as ulnar impaction syndrome. This system typically includes plates and screws to stabilize the bone after shortening. The procedure helps in reducing wrist pain and improving range of motion for patients with specific wrist pathologies.
Clinical Applications
This device is commonly used in orthopedic surgery, particularly in cases where patients suffer from ulnar impaction syndrome, a condition where the ulna is longer than the radius causing wrist pain. It is used in hospital operating rooms and outpatient surgical centers. The typical patient population includes adults with chronic wrist pain due to ulnar variance.
Indications for Use
The FDA-cleared indications for this device include surgical interventions for patients with ulnar impaction syndrome. It is intended for those who experience wrist pain due to the ulna being longer than the radius, leading to joint stress.
Practical Considerations
The system may come in various sizes to accommodate different patient anatomies. Surgeons should ensure compatibility with existing surgical instruments and be familiar with the specific technique required for ulnar shortening procedures. Preoperative planning is crucial for optimal outcomes.
Frequently Asked Questions
What is the Avanti Orthopaedics Ulnar Shortening System used for?
It is used to surgically shorten the ulna to treat ulnar impaction syndrome and relieve wrist pain.
What specialties typically use this device?
Orthopedic surgeons typically use this device in surgical procedures related to wrist conditions.
What are the FDA-cleared indications?
The device is indicated for surgical treatment of ulnar impaction syndrome, where the ulna is longer than the radius causing wrist pain.
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.