# K080875: Pigalileo 4TH Generation System

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc.
- Decided: Jul 18, 2008 after 109 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: 6 generations back to K010612 (2001). 21 ancestors in all.
79 later devices descend from it; 1 cites it directly.
0 of 101 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061362: Pigalileo Total Knee Replacement (TKR) System, Plus Orthopedics AG (2006) Summary page 1.
- K070731: Pigalileo Total Hip Replacement (THR) System, Plus Orthopedics AG (2007) Summary page 1.

## Most influential descendants
- 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
- K110670: VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws, Peri-Loc Ankle Fusion Plates (2011), 69 descendants of its own
- K121425: Ortholoc 3DI Ankle Fusion Plating System (2012), 53 descendants of its own

## Indications for use
The PiGalileo 4th Generation System is intended for use as a stereotaxic instrument to assist in the positioning of total knee and total hip replacement components intra-operatively. The system is a computer controlled image guided system equipped with a three-dimensional tracking sub-system. The PiGalileo System is intended to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks; as such instruments are precisely positioned relative to these axes by displaying their locations. This allows for accurate positioning of instruments used for total knee and total hip replacement surgery and provides intraoperative measurements of bone alignment.

Source page: https://510kreport.com/device/K080875
Methodology: https://510kreport.com/methodology