# K200765: Genius / Genuin Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Biorad Medisys Pvt, Ltd.
- Decided: May 5, 2021 after 407 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K870730 (1987). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182301: PFC SIGMA Knee System, DePuy Orthopaedics, Inc. (2019) Summary page 4.

## Indications for 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, polyarthritis, Correction of functional deformities. Post-traumatic 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.

Source page: https://510kreport.com/device/K200765
Methodology: https://510kreport.com/methodology