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avanta orthopaedics trapezial implant
Avanta Orthopaedics
Summary: The Avanta Orthopaedics Trapezial Implant is used in hand surgery, specifically for trapeziometacarpal joint arthroplasty. It is utilized by orthopedic surgeons to treat conditions like arthritis at the base of the thumb.
FDA Clearance Information
Pathway
510K
Number
K964381 ↗
Decision Date
January 22, 1997
Product Code
KYI
Device Class
Class 2
Evidence
0 studies
The Avanta Orthopaedics Trapezial Implant was cleared through the FDA 510k pathway on January 22, 1997. Manufactured by Avanta Orthopaedics, it is a Class 2 medical device.
What It Is
The Avanta Orthopaedics Trapezial Implant is a prosthetic device designed to replace the trapezium bone in the wrist, commonly used in trapeziometacarpal joint arthroplasty. This implant helps restore function and relieve pain in patients suffering from arthritis at the base of the thumb. It is typically made from biocompatible materials that integrate well with the surrounding bone and tissue.
Clinical Applications
This implant is commonly used in orthopedic and hand surgery settings, particularly for patients with osteoarthritis or rheumatoid arthritis affecting the thumb's basal joint. It is typically employed in outpatient surgical centers or hospitals where hand surgeries are performed. The patient population includes adults, often middle-aged or older, who experience significant pain and reduced function due to joint degeneration.
Indications for Use
The FDA indications for this implant include use in patients with degenerative or inflammatory arthritis of the trapeziometacarpal joint. It is intended for those who have not responded to conservative treatments and require surgical intervention to restore hand function.
Practical Considerations
The implant comes in various sizes to accommodate different patient anatomies, and proper sizing is crucial for optimal outcomes. Surgeons should be familiar with the specific surgical techniques required for implantation, including the approach to the trapeziometacarpal joint and fixation methods.
Frequently Asked Questions
What is Avanta Orthopaedics Trapezial Implant used for?
It is used for trapeziometacarpal joint arthroplasty to treat arthritis at the base of the thumb.
What specialties typically use this device?
Orthopedic surgeons and hand surgeons typically use this device.
What are the FDA-cleared indications?
It is indicated for patients with degenerative or inflammatory arthritis of the trapeziometacarpal joint who require surgical intervention.
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.