# K020264: Repicci II Unicondylar Knee System

- Pathway: 510(k) (Special)
- Applicant: Biomet Orthopedics, Inc.
- Decided: Feb 8, 2002 after 14 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 K971938 (1997). 1 ancestor in all.
4 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)
- K971938: Repicci II Unicondylar Knee, Biomet, Inc. (1997) Summary page 1.

## Most influential descendants
- K063515: Titanium Repicci II Unicondylar Femoral Knee Components Cocr Repicci II Unicondylar Knee (2007), 2 descendants of its own
- K203341: ACS LD Uni FB Knee System (2021), 1 descendant of its own
- K260037: implantcast Packaging System Update (2026), 0 descendants of its own
- K072704: Unicompartmental Knee (2008), 0 descendants of its own

## Indications for use
The indications for use for the Repicci II™ Unicondylar Knee System are for painful and disabled knee joint resulting from osteoarthritis. rheumatoid arthritis. traumatic arthritis where one or more compartments are involved: the correction of varus. valgus. or posttraumatic deformity: and the correction or revision of unsuccessful osteotomy. arthrodesis. or failure of previous joint replacement procedure. This device is for use with bone cement.

Source page: https://510kreport.com/device/K020264
Methodology: https://510kreport.com/methodology
