# K180317: EVOLUTION® Knee Systems – MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION® Revision Tibial System, EVOLUTION® Revision CCK System

- Pathway: 510(k) (Traditional)
- Applicant: Microport Orthopedics, Inc.
- Decided: May 4, 2018 after 88 days
- Product code: MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3565
- 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 K043083 (2005). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152298: EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE Bullet-Tipped Keels, ADVANCE BIOFOAM Tibial Base, Microport Orthopedics, Inc. (2015) Summary page 4.
- K162026: EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions, Microport Orthopedics, Inc. (2017) Summary page 4.
- K171389: EVOLUTION Revision CCK System, Microport Orthopedics, Inc. (2017) Summary page 4.

## Indications for use
The EVOLUTION® BIOFOAM® Tibial, EVOLUTION® Revision Tibial, and EVOLUTION® Revision CCK Systems are 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® BIOFOAM® Tibial System implants are for cementless use only. The EVOLUTION® Revision Tibial and EVOLUTION® Revision CCK Systems are for cemented use only.

Source page: https://510kreport.com/device/K180317
Methodology: https://510kreport.com/methodology