# K971938: Repicci II Unicondylar Knee

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Aug 25, 1997 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
101 later devices descend from it; 14 cite it directly.
0 of 102 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

## Recalls of this device
- Feb 17, 2017 · Class II · Z-1863-2017: Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

## Indications for use
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/K971938
Methodology: https://510kreport.com/methodology