# K083565: Pigalileo Total Hip Replacement (THR) Software Application V3.0

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Feb 20, 2009 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: 6 generations back to K010612 (2001). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

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

## Indications for use
The Smith & Nephew PiGalileo Total Hip Replacement (THR) V3.0 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. hip,.center, pelvic plane etc.). Examples of surgical procedures includebut are not limited to: · Primary total hip replacement · Revision hip surgery · Minimally invasive hip arthroplasty

Source page: https://510kreport.com/device/K083565
Methodology: https://510kreport.com/methodology