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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 ?
510(k)
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.
FDA-Cleared Indications
- Replacement of the trapezium bone in the thumb carpometacarpal joint
- Treatment of arthritis affecting the thumb carpometacarpal joint
- Use in patients with pain and functional impairment related to thumb CMC joint degeneration
Clinical Applications
- Trapezium replacement during surgery for thumb carpometacarpal joint arthritis
- Treatment of advanced thumb CMC joint degeneration when conservative care has not provided adequate relief
- Restoration of the joint space and thumb function after removal of the arthritic trapezium
Practical Considerations
- The implant is available in multiple sizes; selection should match the patient's anatomy and the condition of the surrounding bone.
- The device is intended for use by trained orthopedic or hand surgeons using the labeled surgical technique.
- Bone quality, ligament stability, soft-tissue condition and the degree of joint degeneration should be assessed before implantation.
- The FDA record and supplied text do not establish a specific MRI safety labeling claim; MRI compatibility should be confirmed from the current device labeling or manufacturer.
- Potential contraindications and precautions should be reviewed in the current instructions for use, including infection, inadequate bone stock and medical conditions that impair healing.
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.