# K020741: Unicondylar Knee

- Pathway: 510(k) (Traditional)
- Applicant: Encore Orthopedics, Inc.
- Decided: Jun 4, 2002 after 90 days
- Product code: HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3530
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K971938 (1997). 4 ancestors in all.
81 later devices descend from it; 4 cite it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971938: Repicci II Unicondylar Knee, Biomet, Inc. (1997) Summary page 1.
- K980665: Repicci II Unicondylar Knee All Poly Tibial Components, Biomet, Inc. (1998) Summary page 1.
- K010810: Depuy Preservation Unicondylar Knee Prosthesis, DePuy Orthopaedics, Inc. (2001) Summary page 1.
- K012591: Advance Unicondylar Knee System, Wrightmedicaltechnologyinc (2001) Summary page 1.

## Most influential descendants
- 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
- K072368: Conformis Metal Backed Tibial Component (2007), 31 descendants of its own

## Recalls of this device
- Aug 9, 2007 · Not classified · Z-0009-2008: Angled Insert Impactor may scratch Tibial Insert on the articulating surface, causing increased wear at the damaged site.
- Aug 9, 2007 · Not classified · Z-0010-2008: Angled Insert Impactor may scratch Tibial Insert on the articulating surface, causing increased wear at the damaged site.

## Indications for use
Intended for partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. The device is a single use implant intended for implantation with bone cement.

Source page: https://510kreport.com/device/K020741
Methodology: https://510kreport.com/methodology