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schlein tri-surface ankle
Orthopedic Equipment
Summary: The Schlein Tri-Surface Ankle is an orthopedic device used primarily in the treatment of ankle conditions requiring joint stabilization or replacement. It is typically utilized by orthopedic surgeons in both hospital and outpatient settings.
FDA Clearance Information
Pathway
510K
Number
K800530 ↗
Decision Date
April 2, 1980
Product Code
HSN
Device Class
Class 2
Evidence
0 studies
The Schlein Tri-Surface Ankle was cleared through the FDA 510(k) pathway on April 2, 1980. Manufactured by Orthopedic Equipment, it is classified as a Class 2 device under product code HSN.
What It Is
The Schlein Tri-Surface Ankle is a medical device designed for use in ankle joint stabilization or replacement procedures. It features a tri-surface design that aims to mimic the natural movement of the ankle joint, providing enhanced mobility and stability. This device is typically used in cases where the ankle joint is compromised due to injury, arthritis, or other degenerative conditions.
Clinical Applications
Commonly used in orthopedic surgery, the Schlein Tri-Surface Ankle is employed in procedures involving ankle joint replacement or stabilization. It is particularly relevant in treating patients with severe arthritis, traumatic injuries, or congenital deformities affecting the ankle. The device is used in both inpatient and outpatient surgical settings, often in specialized orthopedic centers.
Indications for Use
The FDA indications suggest that the Schlein Tri-Surface Ankle is intended for patients who require surgical intervention for ankle joint stabilization or replacement. This includes individuals with severe arthritis, significant joint trauma, or other conditions leading to joint instability.
Practical Considerations
The Schlein Tri-Surface Ankle comes in various sizes to accommodate different patient anatomies. It is compatible with standard orthopedic surgical instruments and requires precise surgical technique for optimal outcomes. Surgeons should be familiar with the device's design and functionality to ensure proper implantation.
Frequently Asked Questions
What is Schlein Tri-Surface Ankle used for?
It is used for ankle joint stabilization or replacement in patients with conditions like severe arthritis or traumatic injuries.
What specialties typically use this device?
Orthopedic surgeons specializing in foot and ankle surgery commonly use this device.
What are the FDA-cleared indications?
The device is indicated for patients needing surgical intervention for ankle joint stabilization or replacement due to conditions like arthritis or trauma.
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.