# K102380: Evolution MP Total Knee System

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Jan 7, 2011 after 137 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: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K033890 (2004). 3 ancestors in all.
11 later devices descend from it; 5 cite it directly.
0 of 15 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 1.
- K063731: Advance Stature Femoral Component, Wrightmedicaltechnologyinc (2007)
- K033890: Advance Double High Insert, Wrightmedicaltechnologyinc (2004) Summary page 1.

## Cited in the summary but kept off the family tree
- K073524: ADVANCE Total Knee System. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K072626: ADVANCE Total Knee System. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K060617: PTS Panels HDL Cholesterol Test Strips, Polymer Technology Systems, Inc. (2006). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K084334: AXIOM Total Knee System. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K113325: Evolution MP Adaptive CS Insert (2011), 7 descendants of its own
- K131679: Evolution MP Adaptive PS Tibial Insert (2013), 6 descendants of its own
- K140735: Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS Inserts (2014), 5 descendants of its own
- K182251: EVOLUTION NitrX Medial-Pivot Knee (2019), 4 descendants of its own
- K243574: Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique (2025), 1 descendant of its own

## Recalls of this device
- Oct 29, 2024 · Class II · Z-0699-2025: Femoral implant porous size 5 right primary and femoral implant non-porous size 6 left primary have correct markings on devices, but may have incorrect packaging.
- May 3, 2024 · Class II · Z-2244-2024: One confirmed incident has been received that EFSRN4PR, lot number MP1982170, Size 4 Evolution MP Non-Porous Femoral Right was opened during surgery and contained part number EFSRN3PL, lot number MP19
- Oct 28, 2022 · Class II · Z-0276-2023: One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot 1916715, size 7 Evolution MP Tibial Base, in t
- Oct 28, 2022 · Class II · Z-0275-2023: One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot 1916715, size 7 Evolution MP Tibial Base, in t

## Indications for use
The EVOLUTION MP Total Knee System is indicated for use in knee arthroplasty in skeletally mature patients with 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; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques. The EVOLUTION Total Knee System is for cemented use only.

Source page: https://510kreport.com/device/K102380
Methodology: https://510kreport.com/methodology