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avanta orthopaedics trapezium implant
Avanta Orthopaedics
Summary: The Avanta Orthopaedics Trapezium Implant is used for thumb carpometacarpal joint arthritis, providing joint replacement solutions for orthopedic surgeons treating arthritis in the hand.
FDA Clearance Information
Pathway
510K
Number
K965204 ↗
Decision Date
June 3, 1997
Product Code
KYI
Device Class
Class 2
Evidence
0 studies
The Avanta Orthopaedics Trapezium Implant was cleared through the FDA 510k pathway on June 3, 1997. It is manufactured by Avanta Orthopaedics and is classified as a Class 2 device.
What It Is
The Avanta Orthopaedics Trapezium Implant is a prosthetic device designed to replace the trapezium bone in the thumb carpometacarpal (CMC) joint. It is used primarily in patients with arthritis of the CMC joint to alleviate pain and restore function. The implant is typically made of biocompatible materials that integrate with the surrounding bone and tissue.
Clinical Applications
This implant is commonly used in orthopedic and hand surgery settings for patients with advanced thumb CMC joint arthritis. It is particularly beneficial for patients who have not responded to conservative treatments such as splinting or medication. The device is used in surgical procedures to improve thumb mobility and reduce pain, especially in older adults or those with significant joint degeneration.
Indications for Use
The FDA-cleared indications suggest that this implant is intended for patients with arthritis of the thumb CMC joint, particularly those who experience significant pain and functional impairment. It is suitable for patients who have not found relief from non-surgical interventions.
Practical Considerations
The implant comes in various sizes to accommodate different patient anatomies. Surgeons should consider the patient's bone quality and joint condition when selecting the implant. Proper surgical technique is crucial to ensure optimal placement and longevity of the implant.
Related Literature
A study followed four Japanese patients over 15 years who received the Avanta implant for thumb CMC joint arthritis. Despite radiographic loosening in all cases, three patients reported excellent outcomes, and one reported good outcomes, with no severe pain or significant problems. The study highlights the implant's long-term efficacy but notes the limitation of a small sample size.
Frequently Asked Questions
What is the Avanta Orthopaedics Trapezium Implant used for?
It is used for replacing the trapezium bone in the thumb CMC joint in patients with arthritis to relieve pain and improve function.
What specialties typically use this device?
Orthopedic surgeons and hand surgeons commonly use this device in surgical settings.
What are the FDA-cleared indications?
The device is indicated for patients with thumb CMC joint arthritis who require surgical intervention due to pain and functional limitations.
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.