# K012591: Advance Unicondylar Knee System

- Pathway: 510(k) (Abbreviated)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Nov 2, 2001 after 84 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
No predicates in its family tree.
90 later devices descend from it; 7 cite it directly.
0 of 91 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
- K020741: Unicondylar Knee (2002), 81 descendants of its own
- K022437: Uni Knee (2002), 80 descendants of its own
- K080368: Mako Surgical Corp. Unicondylar Knee Implant System II (2008), 56 descendants of its own
- K082172: Mako Modular Knee Compartmental Implant System (2008), 51 descendants of its own
- K090763: Restoris Multicompartmental Knee (MCK) System (2009), 50 descendants of its own

## Indications for use
Indicated for use in kuee 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 deformuty; 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 deformmties 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/K012591
Methodology: https://510kreport.com/methodology