# K222816: Opulent TiNbN Coated Knee

- Pathway: 510(k) (Traditional)
- Applicant: Meril Healthcare Pvt., Ltd.
- Decided: Nov 18, 2022 after 60 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: 8 generations back to K936079 (1994). 40 ancestors in all.
No later device cites it as a predicate yet.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212839: Opulent TiNbN Coated Knee, Meril Healthcare Pvt., Ltd. (2021) Summary page 5.

## Indications for use
The Opulent TiNbN Coated Knee is indicated for the following: • Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, and polyarthritis. • Correction of functional deformities. • Post-traumatic loss of knee join contour, particularly when there is patellofemoral erosion, dysfunction, and/or prior patellectomy. • Moderate valgus, varus, or flexion trauma. • Knee fractures untreatable by other methods. • Revision surgery where sufficient bone and soft tissue integrity are present. The Opulent TiNbN Coated Knee is intended for cemented use only. This device is for single use only.

Source page: https://510kreport.com/device/K222816
Methodology: https://510kreport.com/methodology