# K012800: Symmetric Unicompartmental Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Whiteside Biomechanics, Inc.
- Decided: May 3, 2002 after 255 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 K955778 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955778: Natural-Knee II Unicompartmentalknee System, Intermedics Orthopedics (1996) Summary page 1.

## Indications for use
The Symmetric Unicom{paa\mental Knee System is for Cemented Use Only and is indicated for restroing ejthgr compartment of a knee that has been damaged by rtheumatoid arthritis, post-traumatic arthritis, osteoarthritis, failed osteotomies or hemiarthroplasties.

Source page: https://510kreport.com/device/K012800
Methodology: https://510kreport.com/methodology