📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use in surgical treatment of damaged or deficient tendons when a tendon spacer is indicated for structural support.
- Use during tendon repair or reconstruction as specified by the device labeling.
Clinical Applications
- Providing temporary support during surgical tendon repair.
- Supporting tendon reconstruction when native tendon tissue is damaged or deficient.
- Maintaining tendon spacing or alignment during healing, when consistent with the device labeling.
- Use in orthopedic tendon procedures involving the hand, wrist, foot, or other labeled anatomical sites.
Practical Considerations
- The available FDA record does not provide complete details about the device material, dimensions, implant duration, or anatomical limitations; clinicians should consult the original labeling and surgical technique.
- Size and configuration should be selected according to the tendon, defect, and patient anatomy.
- The device should be handled with sterile technique and used only with compatible surgical instruments and fixation methods specified by the manufacturer.
- MRI safety cannot be determined from the available record. Review the current device labeling before MRI, especially if the implant contains metal or other MRI-conditional components.
- Contraindications, infection risk, tissue quality, allergy or sensitivity to device materials, and the feasibility of definitive tendon repair should be assessed before implantation.
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.