# K243574: Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique

- Pathway: 510(k) (Traditional)
- Applicant: Microport Orthopedics, Inc.
- Decided: Feb 18, 2025 after 91 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: 16 generations back to K941847 (1994). 201 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 202 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140735: Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS Inserts, Microport Orthopedics, Inc. (2014) Summary page 5.
- K093552: Evolution MP Total Knee System, Wrightmedicaltechnologyinc (2010) Summary page 5.
- K102380: Evolution MP Total Knee System, Wrightmedicaltechnologyinc (2011) Summary page 5.
- 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.
- 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 5.
- K170288: BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular Shell, Microport Orthopedics, Inc. (2017) Summary page 5.
- K182125: EVOLUTION Stemmed CS Femur, Microport Orthopedics, Inc. (2018) Summary page 6.
- K182251: EVOLUTION NitrX Medial-Pivot Knee, Mircoport Orthopedics, Inc. (2019) Summary page 6.
- K173890: GMK Sphere - Kinematic Alignment, Medacta International S.A. (2018) Summary page 6.
- K172524: Zimmer Persona Personalized Knee System, Zimmer, Inc. (2018) Summary page 6.

## Most influential descendants
- K253728: EVOLUTION® AM BIOFOAM® Tibial System (2026), 0 descendants of its own

## Indications for use
The Evolution® Total Knee Systems can be implanted using the Kinematic Alignment technique. When the Kinematic Alignment approach is utilized, the devices are indicated for the following conditions: 1) noninflammatory 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 and Evolution® Revision Tibia Base.

Source page: https://510kreport.com/device/K243574
Methodology: https://510kreport.com/methodology