# K070731: Pigalileo Total Hip Replacement (THR) System

- Pathway: 510(k) (Traditional)
- Applicant: Plus Orthopedics AG
- Decided: Jul 31, 2007 after 138 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: 5 generations back to K010612 (2001). 20 ancestors in all.
81 later devices descend from it; 2 cite it directly.
0 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060468: Vectorvision Hip, Brainlab AG (2006) Summary page 2.
- K050752: Aesculap Orthopilot 2 Tha V 2.0, Aesculap, Inc. (2005) Summary page 2.
- K022365: Stryker Navigation System - Hip Module, Stryker Instruments (2003) Summary page 2.
- K061362: Pigalileo Total Knee Replacement (TKR) System, Plus Orthopedics AG (2006) Summary page 2.

## Most influential descendants
- K080875: Pigalileo 4TH Generation System (2008), 79 descendants of its own
- 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

## Indications for use
The PiGalileoTM Total Hip Replacement (THR) 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 utilized 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 some surgical procedures include but are not limited to: Primary total hip replacement Revision hip surgery Minimally invasive hip arthroplasty

Source page: https://510kreport.com/device/K070731
Methodology: https://510kreport.com/methodology