📋 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 ?
510(k)
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.
FDA-Cleared Indications
- Use as components of the GMK-Sphere total knee replacement system in patients requiring knee arthroplasty.
- Use in adults with painful and disabling knee-joint disease caused by degenerative, rheumatoid, or post-traumatic arthritis.
- Use to replace damaged knee-joint surfaces and restore knee-joint function when conservative treatment is inadequate.
Clinical Applications
- Primary total knee arthroplasty for severe knee arthritis.
- Knee replacement for osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis.
- Use as a tibial insert that articulates with the femoral component of a compatible GMK-Sphere knee system.
- Use of a resurfacing patella component when patellar resurfacing is included in the knee replacement procedure.
Practical Considerations
- The inserts and patella components are available in multiple sizes; the surgeon selects components based on the patient's anatomy and the compatible GMK-Sphere system components.
- These components are intended for use with compatible GMK-Sphere knee implants and should not be mixed with components that are not approved for the system unless specifically permitted by labeling.
- Implantation requires accurate bone preparation, alignment, sizing, and fixation by an orthopedic surgeon.
- The device is made from vitamin E highly crosslinked UHMWPE; handling should avoid damage, contamination, or scratching of the bearing surfaces.
- MRI safety depends on the complete implanted knee system and its metallic components. Patients should provide the implant information to the MRI facility, which will determine scanning conditions from the current labeling.
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.