# K182251: EVOLUTION NitrX Medial-Pivot Knee

- Pathway: 510(k) (Traditional)
- Applicant: Mircoport Orthopedics, Inc.
- Decided: May 16, 2019 after 269 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: 2 generations back to K033890 (2004). 4 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093552: Evolution MP Total Knee System, Wrightmedicaltechnologyinc (2010) Summary page 4.
- K102380: Evolution MP Total Knee System, Wrightmedicaltechnologyinc (2011) Summary page 4.

## Most influential descendants
- K243574: Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique (2025), 1 descendant of its own
- K241180: Consensus Knee System with TiNbN (2025), 1 descendant of its own
- K253728: EVOLUTION® AM BIOFOAM® Tibial System (2026), 0 descendants of its own
- K260796: Tahoe Unicondylar Knee System with TiNbN Overcoat (2026), 0 descendants of its own

## Indications for use
The EVOLUTION® NitrX™ Medial-Pivot Knee is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1. Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis 2. Inflammatory degenerative joint disease, including rheumatoid arthritis; 3. Correction of functional deformity 4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques. The EVOLUTION® Medial-Pivot Total Knee System Nonporous implants are for cemented use only.

Source page: https://510kreport.com/device/K182251
Methodology: https://510kreport.com/methodology