# K192653: Perseus

- Pathway: 510(k) (Traditional)
- Applicant: Orthokey Italia S.R.L.
- Decided: Sep 9, 2020 after 351 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K983831 (1999). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163379: KneeAlign 2 System, Orthalign, Inc. (2017) Summary page 4.

## Indications for use
PERSEUS is a computer-controlled system, intended to assist in distal femoral resection and tibial resection during Total Knee Arthroplasty, determining reference alignment axes in relation to anatomical and instrumentation structures during stereotaxic orthopaedic surgical procedures.

Source page: https://510kreport.com/device/K192653
Methodology: https://510kreport.com/methodology