# K090420: Smith & Nephew Pigalileo Screw Targeting System V 1.0

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc.
- Decided: May 27, 2009 after 98 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: 7 generations back to K010612 (2001). 26 ancestors in all.
78 later devices descend from it; 1 cites it directly.
0 of 105 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080875: Pigalileo 4TH Generation System, Smith & Nephew, Inc. (2008) Summary page 1.
- K080520: Non Sterile, Powder Free Nitrile Examination Glove, Blue, Polymer Coating with Chemotherapy Claim, Siam Sempermed Corp., Ltd. (2008)
- K012448: Vectorvision Trauma, Brainlab AG (2002) Summary page 1.

## Cited in the summary but kept off the family tree
- K080381: Quest Diagnostics Methamphetamine Micro-Plate Eia, Quest Diagnostics, Inc. (2008). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- 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
- K140397: Paralock Plating System / Tuffnek Screw (2014), 31 descendants of its own

## Indications for use
The Smith & Nephew PiGalileo Screw Targeting System is intended to be an intraoperative image guided localization system. It is a computer assisted orthopedic surgery tool to aid the surgeon with drill positioning for screws during intramedullary nail implantation. It provides information to the surgeon that is used to place surgical instruments during surgery utilizing intraoperatively obtained electromagnetic tracking data. The Smith & Nephew PiGalileo Screw Targeting System V1.0 is indicated for long bone fractures treated with intramedullary nails in which the use of stereotactic surgery may be appropriate.

Source page: https://510kreport.com/device/K090420
Methodology: https://510kreport.com/methodology