# K014171: Advance Unicondylar Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Mar 15, 2002 after 85 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: 1 generation back to K881779 (1988). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012591: Advance Unicondylar Knee System, Wrightmedicaltechnologyinc (2001) Summary page 2.
- K881779: Whiteside Ortholoc II Unicondylar Knee System, Dow Corning Wright (1988) Summary page 2.

## Most influential descendants
- K022211: HLS Uni Evolution Prosthesis (2003), 1 descendant of its own
- K120262: HLS Uni Evolution & U-Kneetec (2012), 0 descendants of its own
- K100973: Evolution Unicondylar Knee System (2010), 0 descendants of its own

## Indications for use
Indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function 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 5) treatment of fractures that are unmanageable using other techniques. 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 ADVANCE® Unicondylar Knee System components are for single use only. The ADVANCE® Unicondylar Knee System components are for cemented use only.

Source page: https://510kreport.com/device/K014171
Methodology: https://510kreport.com/methodology