# K010204: Stryker Navigation System-Knee Module

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corp.
- Decided: Aug 31, 2001 after 220 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
No predicates in its family tree.
158 later devices descend from it; 5 cite it directly.
0 of 159 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K013569: Orthopilot 2 (2002), 153 descendants of its own
- 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

Source page: https://510kreport.com/device/K010204
Methodology: https://510kreport.com/methodology