# K241180: Consensus Knee System with TiNbN

- Pathway: 510(k) (Traditional)
- Applicant: Shalby Advanced Technologies
- Decided: Jan 14, 2025 after 260 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: 6 generations back to K933785 (1995). 39 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110950: Consensus Knee System, Consensus Orthopedics, Inc. (2011) Summary page 5.
- K001456: Consensus Knee System, Hayes Medical, Inc. (2000) Summary page 5.
- K182251: EVOLUTION NitrX Medial-Pivot Knee, Mircoport Orthopedics, Inc. (2019) Summary page 5.
- K122239: Foundation Knee System with Tinbn Coating Foundation PS Knee System with Tinbn Coating 3DKNEE System with Tinbn Coating, Encore Medical L.P. (2013) Summary page 5.

## Most influential descendants
- K260796: Tahoe Unicondylar Knee System with TiNbN Overcoat (2026), 0 descendants of its own

## Indications for use
The indications for use are: A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis B. Failed osteotomy or unicompartmental replacements C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists D. The non-porous (uncoated, coated with CoCr beads without Titanium, and uncoated with a TiNbN overcoat) components may only be used with cement E. The porous coated (CoCr beads with Titanium) components may be used with or without cement

Source page: https://510kreport.com/device/K241180
Methodology: https://510kreport.com/methodology