# K021327: Orthopilot Hto Module

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: Jul 25, 2002 after 90 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: 2 generations back to K003347 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013569: Orthopilot 2, Aesculap, Inc. (2002)
- K003347: Orthopilot, Kinamed, Inc. (2001) Summary page 2.
- K010204: Stryker Navigation System-Knee Module, Stryker Corp. (2001)
- K010612: Vectorvision Knee, Brainlab AG (2001)

## Indications for use
The Orthopilot@HTO module is designed to assist an orthopedic surgeon to navigate the two bone cuts to form the wedge for correction of the leg axis.

Source page: https://510kreport.com/device/K021327
Methodology: https://510kreport.com/methodology