# K093552: Evolution MP Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Mar 4, 2010 after 107 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: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
38 later devices descend from it; 15 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K141934: Physica KR Knee System (2015), 18 descendants of its own
- K102380: Evolution MP Total Knee System (2011), 11 descendants of its own
- K190911: Physica KR Liner and SMR Reverse Humeral Liner (2019), 8 descendants of its own
- K151266: Physica CR Knee System (2015), 8 descendants of its own
- K220792: SMR Reverse Liner (2022), 7 descendants 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
- Feb 2, 2015 · Class II · Z-1249-2015: Some units of the EVOLUTION Tibial Base was affected by a casting tool issue which caused varying retaining wall thickness and keel offset in the finished product.

## Indications for use
The EVOLUTIONTM MP Total Knee System is indicated for use in knee artbroplasty in skeletally mature patients with the following conditions: 1. noninflammuatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascLular 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 5. treatment of fractures that are unmanageable using other techniques. EVOLUTIONTM MP Total Knee System non-porous components are for cemented use only.

Source page: https://510kreport.com/device/K093552
Methodology: https://510kreport.com/methodology