đź“‹ FDA Reference
gmk-sphere tibial inserts flex tibial insert cr and resurfacing patella made of e-cross vitamin e highly crosslinked uhmwpe
Medacta International
Summary: The GMK-Sphere Tibial Inserts are orthopedic implants used in knee replacement surgeries. Designed for use by orthopedic surgeons, they help improve joint function in patients with knee joint degeneration.
FDA Clearance Information
Pathway
510K
Number
K202022 ↗
Decision Date
September 18, 2020
Product Code
JWH
Device Class
Class 2
Evidence
0 studies
The GMK-Sphere Tibial Inserts were cleared through the FDA 510k pathway on September 18, 2020. Manufactured by Medacta International, this Class 2 device is intended for orthopedic use.
What It Is
The GMK-Sphere Tibial Inserts are components used in total knee arthroplasty (TKA) procedures. Made from E-CROSS Vitamin E highly crosslinked UHMWPE, these inserts are designed to provide enhanced wear resistance and longevity. They work by replacing the damaged tibial cartilage and part of the bone, providing a smooth surface for the femoral component to articulate against.
Clinical Applications
These tibial inserts are commonly used in orthopedic surgeries, specifically total knee arthroplasty, to treat patients with severe osteoarthritis or other degenerative joint diseases. They are typically used in hospital settings by orthopedic surgeons. The device is suitable for adult patients who require knee joint replacement to restore mobility and reduce pain.
Indications for Use
The GMK-Sphere Tibial Inserts are indicated for patients with severe knee joint degeneration due to osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis. They are used in knee replacement surgeries to improve joint function and reduce pain.
Practical Considerations
The GMK-Sphere Tibial Inserts are available in various sizes to accommodate different patient anatomies. They are compatible with other components of the GMK-Sphere knee system. Surgeons should ensure proper alignment and fixation during implantation to optimize outcomes.
Frequently Asked Questions
What is GMK-Sphere Tibial Inserts used for?
The GMK-Sphere Tibial Inserts are used in total knee arthroplasty to replace damaged tibial cartilage and bone, improving joint function and reducing pain.
What specialties typically use this device?
Orthopedic surgeons typically use this device in knee replacement surgeries.
What are the FDA-cleared indications?
The device is indicated for patients with severe knee joint degeneration due to conditions like osteoarthritis, requiring knee replacement surgery.
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.