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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 ?
510(k)
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.
FDA-Cleared Indications
- Treatment of degenerative arthritis involving the trapeziometacarpal joint.
- Treatment of inflammatory arthritis involving the trapeziometacarpal joint.
- Use in patients whose symptoms have not adequately improved with conservative treatment and who require surgical joint reconstruction.
Clinical Applications
- Trapezial implant arthroplasty for arthritis at the base of the thumb.
- Replacement of the trapezium during surgical treatment of trapeziometacarpal joint disease.
- Treatment of painful thumb basal-joint arthritis when nonsurgical care has been unsuccessful.
- Reconstruction intended to improve thumb motion and hand function in appropriately selected patients.
Practical Considerations
- The implant is available in different sizes; accurate sizing and positioning are important for matching the patient's anatomy and restoring joint mechanics.
- The surgeon should follow the device-specific surgical technique, including the recommended approach, preparation of the trapezial space and fixation method.
- The device is intended for the trapeziometacarpal joint and should not be assumed to be appropriate for other joints or indications without supporting labeling.
- MRI safety depends on the implant's material and the manufacturer's labeling. Confirm the exact device and current MRI conditions before scanning.
- Contraindications and precautions may include infection, inadequate bone or soft-tissue support, material sensitivity and medical conditions that make surgery unsuitable; the current FDA labeling and surgical judgment should guide selection.
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.