đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Surgical stabilization or replacement of a compromised ankle joint, as described in the available device record.
- Use in patients with ankle-joint conditions associated with severe arthritis, traumatic injury, or instability, subject to the original FDA labeling and surgical judgment.
Clinical Applications
- Ankle-joint replacement surgery.
- Surgical stabilization of an unstable ankle joint.
- Treatment of severe degenerative ankle-joint disease when surgery is indicated.
- Treatment of traumatic ankle-joint damage requiring reconstruction or replacement.
Practical Considerations
- The available record does not identify the materials, component configuration, sizing range, or detailed surgical technique; clinicians should consult the original FDA clearance and manufacturer documentation.
- Implantation requires appropriate orthopedic instruments, accurate component positioning, and assessment of bone quality and ankle alignment.
- MRI safety and conditional scanning parameters are not established in the supplied record. Do not assume the device is MRI safe without confirming its labeling and implant materials.
- Contraindications, infection precautions, postoperative weight-bearing limits, and revision options should be determined from the original labeling and current orthopedic practice.
- The 510(k) clearance indicates substantial equivalence to a predicate device; it is not evidence of a specific clinical success rate or expected implant lifetime.
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.