# K160771: Destiknee Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Meril Healthcare Private Limited
- Decided: Dec 19, 2016 after 273 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: 4 generations back to K936079 (1994). 26 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082019: Freedom Total Knee System, Maxx Orthopedics, Inc. (2009) Summary page 5.
- K090411: Freedom Metal Backed Tibial Component, Maxx Orthopedics, Inc. (2009) Summary page 5.
- K091280: Freedom Total Knee Cruciate Retaining (CR) Femoral Component, Maxx Orthopedics, Inc. (2009) Summary page 5.

## Most influential descendants
- K172936: Destiknee™ Total Knee System (2017), 2 descendants of its own
- K212839: Opulent TiNbN Coated Knee (2021), 1 descendant of its own
- K222816: Opulent TiNbN Coated Knee (2022), 0 descendants of its own

## Indications for use
The DestikneeTM- Total Knee System is indicated for patients with severe knee pain and disability due to: 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. The DestikneeTM Total Knee System is intended for cemented use only. This device is for single use only.

Source page: https://510kreport.com/device/K160771
Methodology: https://510kreport.com/methodology