# K253728: EVOLUTION® AM BIOFOAM® Tibial System

- Pathway: 510(k) (Traditional)
- Applicant: Microport Orthopedics, Inc.
- Decided: Aug 21, 2026 after 270 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: 17 generations back to K941847 (1994). 202 ancestors in all.
No later device cites it as a predicate yet.
1 of 202 devices in its family (counting itself) has 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 5.
- K243574: Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique, Microport Orthopedics, Inc. (2025) Summary page 5.

## Indications for use
The EVOLUTION® AM BIOFOAM® Tibial System 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® AM BIOFOAM® Tibial System is for uncemented use only. The EVOLUTION® AM BIOFOAM® Tibial System can be implanted using the Kinematic Alignment technique. When the Kinematic Alignment approach is utilized, the devices are indicated for 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 The Evolution® Kinematic Alignment technique may only be used with Evolution® Primary knee components or the Evolution® Stemmed CS Femur.

Source page: https://510kreport.com/device/K253728
Methodology: https://510kreport.com/methodology