# K020298: Galileo Cas/Nav TKR System

- Pathway: 510(k) (Traditional)
- Applicant: Plus Orthopedics
- Decided: May 20, 2002 after 112 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003347 (2001). 1 ancestor in all.
127 later devices descend from it; 1 cites it directly.
0 of 129 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003347: Orthopilot, Kinamed, Inc. (2001) Summary page 2.

## Most influential descendants
- K061362: Pigalileo Total Knee Replacement (TKR) System (2006), 126 descendants of its own
- K070731: Pigalileo Total Hip Replacement (THR) System (2007), 81 descendants of its own
- K080875: Pigalileo 4TH Generation System (2008), 79 descendants of its own
- K090420: Smith & Nephew Pigalileo Screw Targeting System V 1.0 (2009), 78 descendants of its own
- K092497: Smith & Nephew Pigalileo Screw Targeting System, Version 1.1 (2009), 77 descendants of its own

## Recalls of this device
- Jun 20, 2006 · Not classified · Z-0149-2007: Manufacturer recall of the device due to the possibility of pressure plate fractures/breakage.

## Indications for use
The GALILEO CAS/NAV TKR System is intended for computer-assisted navigation of the GALILEO-CAS instruments with the aim to position the implants of the TC-PLUS™ Solution Knee (K000666 — S/E 10/13/00) optimally for the patient.

Source page: https://510kreport.com/device/K020298
Methodology: https://510kreport.com/methodology