# K003347: Orthopilot

- Pathway: 510(k) (Traditional)
- Applicant: Kinamed, Inc.
- Decided: Feb 23, 2001 after 121 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.
436 later devices descend from it; 9 cite it directly.
5 of 437 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
- K021760: Navitrack System-Optical TKR CT-Less, Model 900.120 (2002), 363 descendants of its own
- K043536: Navitrack System - S&N Image Free Knee (2005), 342 descendants of its own
- K013569: Orthopilot 2 (2002), 153 descendants of its own
- K031196: Surgetics Ortho Kneelogics Navigation System (2005), 149 descendants of its own
- K060282: Total Knee Surgetics Navigation System (2006), 147 descendants of its own

Source page: https://510kreport.com/device/K003347
Methodology: https://510kreport.com/methodology