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avanta orthopaedics tendon spacer
Avanta Orthopaedics
Summary: The Avanta Orthopaedics Tendon Spacer is a medical device used to replace or support damaged tendons. It is primarily used by orthopedic surgeons in procedures involving tendon repair or reconstruction.
FDA Clearance Information
Pathway
510K
Number
K964359 ↗
Decision Date
March 25, 1997
Product Code
HXA
Device Class
Class 2
Evidence
0 studies
The Avanta Orthopaedics Tendon Spacer was cleared through the FDA 510(k) pathway on March 25, 1997. It is manufactured by Avanta Orthopaedics and classified as a Class 2 medical device.
What It Is
The Avanta Orthopaedics Tendon Spacer is designed to act as a temporary or permanent support for tendons that have been damaged or are under repair. It is typically made from biocompatible materials that can integrate with surrounding tissues. This device helps maintain the proper alignment and function of tendons during the healing process, reducing the risk of further injury.
Clinical Applications
This tendon spacer is commonly used in orthopedic surgeries, particularly in cases of severe tendon damage or degeneration. It is often utilized in procedures involving the hand, wrist, or foot, where tendon integrity is crucial for function. Patients who have experienced traumatic injuries or have degenerative tendon conditions may benefit from this device.
Indications for Use
The FDA-cleared indications suggest that this device is intended for patients with tendon injuries or conditions that require structural support. It is suitable for use in surgical settings where tendon repair or reconstruction is necessary.
Practical Considerations
The Avanta Orthopaedics Tendon Spacer comes in various sizes to accommodate different anatomical requirements. Surgeons should consider the specific tendon and patient anatomy when selecting the appropriate size. Compatibility with other surgical instruments and techniques should also be considered to ensure optimal outcomes.
Frequently Asked Questions
What is the Avanta Orthopaedics Tendon Spacer used for?
It is used to support or replace damaged tendons during repair or reconstruction surgeries.
What specialties typically use this device?
Orthopedic surgeons, particularly those specializing in hand, wrist, or foot surgery, commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring tendon support or replacement due to injury or degeneration.
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.