# K100973: Evolution Unicondylar Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Aug 10, 2010 after 124 days
- Product code: HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K881779 (1988). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K881779: Whiteside Ortholoc II Unicondylar Knee System, Dow Corning Wright (1988) Summary page 1.
- K012591: Advance Unicondylar Knee System, Wrightmedicaltechnologyinc (2001) Summary page 1.
- K014171: Advance Unicondylar Knee System, Wrightmedicaltechnologyinc (2002) Summary page 1.
- K030193: Advance Less Conforming Tibial Component, Wrightmedicaltechnologyinc (2003) Summary page 1.
- K972770: Advance Ultra-Congruent Tibial Insert, Wrightmedicaltechnologyinc (1997) Summary page 1.
- K093552: Evolution MP Total Knee System, Wrightmedicaltechnologyinc (2010) Summary page 1.

## Indications for use
The EVOLUTION TM Unicondylar 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. correction of functional deformity; 3. revision procedures where other treatments or devices have failed: and treatment of fractures that are unmanageable using other techniques. The EVOLUTION"T Unicondylar Knee System is indicated for patients with unicompartmental joint disease secondary to the above indications with or without valgus, varus, or flexion deformities where all ligaments are intact. The EVOLUTION' Tm Unicondylar Knee System isfor cemented use only.

Source page: https://510kreport.com/device/K100973
Methodology: https://510kreport.com/methodology