# K033668: Navipro Knee Software Module

- Pathway: 510(k) (Traditional)
- Applicant: Kinamed, Inc.
- Decided: Mar 11, 2004 after 111 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). 2 ancestors in all.
40 later devices descend from it; 1 cites it directly.
0 of 43 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 1.
- K020764: Navipro, Kinamed, Inc. (2002) Summary page 1.

## Most influential descendants
- K050897: Navipro Shoulder Software Module (2005), 39 descendants of its own
- K130126: Signature Personalized Patient Care System - Glenoid Guide System (2013), 38 descendants of its own
- K143374: BLUEPRINT Patient Specific Instrumentation (2015), 31 descendants of its own
- K160555: BLUEPRINT Patient Specific Instrumentation (2016), 25 descendants of its own
- K162800: BLUEPRINT Patient Specific Instrumentation (2017), 23 descendants of its own

## Indications for use
The NaviPro TM Knee Software Module is an extension of the NaviProTM Navigation System whose purpose is to measure the spatial orientation of the resection guides and limb alignment during total knee replacement surgery, and for assessing soft tissue balance and changes in the limb mechanical axis as a result of the knee replacement. General spatial measurements may be made and recorded as deemed necessary by the surgeon user.

Source page: https://510kreport.com/device/K033668
Methodology: https://510kreport.com/methodology