# K013569: Orthopilot 2

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Apr 4, 2002 after 157 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: 1 generation back to K003347 (2001). 4 ancestors in all.
153 later devices descend from it; 5 cite it directly.
0 of 158 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003347: Orthopilot, Kinamed, Inc. (2001) Summary page 2.
- K010204: Stryker Navigation System-Knee Module, Stryker Corp. (2001) Summary page 2.
- K010612: Vectorvision Knee, Brainlab AG (2001) Summary page 2.
- K010602: Vectorvision Hip, Brainlab AG (2001) Summary page 2.

## Most influential descendants
- K061362: Pigalileo Total Knee Replacement (TKR) System (2006), 126 descendants of its own
- K050752: Aesculap Orthopilot 2 Tha V 2.0 (2005), 83 descendants of its own
- K070731: Pigalileo Total Hip Replacement (THR) System (2007), 81 descendants of its own
- 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

## Indications for use
The Orthopilot® 2 Navigation Platform is a system for computer-aided navigation of surgical instruments. Its purpose is to optimally position endoprosthesis in arthroplasty such as the Search Evolution Knee system and the Gem Knee system in the patient. It aids the surgeon in accurately positioning the cutting guides, drills and reamers for total endoprosthesis replacement surgery and provides intraoperative measurements of bone alignment. It indicates optimized angles and positions for implant placement. (Does not include an indication for High Tibial Osteotomy (HTO) module).

Source page: https://510kreport.com/device/K013569
Methodology: https://510kreport.com/methodology