# K090313: Pigalileo TKR Base V2.3 and Cas V4.1

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Mar 11, 2009 after 30 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: 5 generations back to K002053 (2000). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082267: Pigalileo Cas, Version 4.0 and TKR Base, Version 2.1, Smith & Nephew, Inc. (2008) Summary page 1.

## Indications for use
The Smith & Nephew PiGalileo Total Knee Replacement (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 used 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 surgical procedures include but are not limited to: * Total knee replacement supporting bone referencing technique * Total knee replacement supporting ligament balancing technique * Minimally invasive total knee replacement

Source page: https://510kreport.com/device/K090313
Methodology: https://510kreport.com/methodology