# K082267: Pigalileo Cas, Version 4.0 and TKR Base, Version 2.1

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Oct 29, 2008 after 79 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: 4 generations back to K002053 (2000). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 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.

## Most influential descendants
- K090313: Pigalileo TKR Base V2.3 and Cas V4.1 (2009), 0 descendants of its own

## Indications for use
The Smith & Nephew PiGatileo System TKR is intended to be used in computer assisted orthopedic surgery to aid the surgeon with bone cuts and implant positioning during joint replacement. Itprovides information to the surgeon that is utilized to place surgical instruments during surgery utilizing anatomical landmarks and other data specifically obtained intraoperatively (e.g. ligament tension, limb alignment, etc.) Examples of some 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/K082267
Methodology: https://510kreport.com/methodology