# K061362: Pigalileo Total Knee Replacement (TKR) System

- Pathway: 510(k) (Traditional)
- Applicant: Plus Orthopedics AG
- Decided: Oct 6, 2006 after 143 days
- Product code: HAW (Neurological 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: 3 generations back to K002053 (2000). 9 ancestors in all.
126 later devices descend from it; 6 cite it directly.
0 of 136 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020298: Galileo Cas/Nav TKR System, Plus Orthopedics (2002) Summary page 1.
- K003347: Orthopilot, Kinamed, Inc. (2001) Summary page 1.
- K013569: Orthopilot 2, Aesculap, Inc. (2002) Summary page 1.
- K021760: Navitrack System-Optical TKR CT-Less, Model 900.120, Orthosoft, Inc. (2002) Summary page 1.
- K043536: Navitrack System - S&N Image Free Knee, Orthosoft, Inc. (2005) Summary page 1.

## Most influential descendants
- 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
- K100107: Smith & Nephew Sureshot Distal Targeting System V2.0 (2010), 75 descendants of its own

## Indications for use
The PiGalileo TKR System is intended to be used in computer-assisted orthopedic surgery to aid the surgeon with bone cuts and implant positioning during joint replacement. It provides information to the surgeon that is utilized to place surgical instruments during surgery utilizing anatomical landmarks and other data specifically obtained intra-operatively (e.g., ligament tension, limb alignment, etc.). Examples of some surgical procedures include but are not limited to: * Total knee replacement supporting both bone referencing and ligament balancing techniques * Minimally invasive total knee replacement

Source page: https://510kreport.com/device/K061362
Methodology: https://510kreport.com/methodology