# K020764: Navipro

- Pathway: 510(k) (Traditional)
- Applicant: Kinamed, Inc.
- Decided: Jun 3, 2002 after 88 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). 1 ancestor in all.
41 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.

## Most influential descendants
- K033668: Navipro Knee Software Module (2004), 40 descendants of its own
- 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

## Indications for use
NaviProTMis a system for computer-aided navigation of surgical instruments whose purpose is to optimally position the acetabular shell during hip replacement surgery, and to report changes in rotational center, limb length, and femoral offset as a result of prosthetic implantation. The system aids the surgeon in accurately positioning the acetabular shell during hip replacement and provides intra-operative measurements of femoral position and orientation in relation to the pelvis. General spatial measurements may be made and recorded as deemed necessary by the surgeon user.

Source page: https://510kreport.com/device/K020764
Methodology: https://510kreport.com/methodology