Search Results
Found 1 results
510(k) Data Aggregation
K Number
K200765Device Name
Genius / Genuin Total Knee System
Manufacturer
Date Cleared
2021-05-05
(407 days)
Product Code
Regulation Number
888.3560Why did this record match?
Applicant Name (Manufacturer) :
Biorad Medisys PVT LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Indicated for use only with bone cement for patients suffering from: Severe knee joint pain, loss of mobility and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, Correction of functional deformities. Posttraumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; Moderate valgus, Varus or flexion trauma. Knee fractures untreatable by other methods.
Device Description
The Genius / Genuin Total Knee System has 3 major components:
- Femoral component
- Tibial component - Includes Tibial Tray and Tibial Insert
- Patellar component
Ask a Question
Ask a specific question about this device
Page 1 of 1