# K231037: MyKnee UNI-ST

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Jun 9, 2023 after 58 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K941847 (1994). 87 ancestors in all.
No later device cites it as a predicate yet.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093806: Myknee Cutting Blocks, Medacta International S.A. (2010) Summary page 4.

## Indications for use
The MyKnee UNI-ST blocks are based on CT or MRI scans of the knee and they are intended for use as anatomical cutting blocks or pin positioners specifically designed for each patient to assist in the intraoperative positioning of the tibial unicompartmental component and to guide the marking of the bone before cutting. The MyKnee UNI-ST blocks are intended for use with MOTO Partial Knee systems when the clinical evaluation complies with clear indications for use. MyKnee UNI-ST blocks are intended for single use only.

Source page: https://510kreport.com/device/K231037
Methodology: https://510kreport.com/methodology