# K050897: Navipro Shoulder Software Module

- Pathway: 510(k) (Traditional)
- Applicant: Kinamed, Inc.
- Decided: May 24, 2005 after 46 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: 3 generations back to K003347 (2001). 3 ancestors in all.
39 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)
- K033668: Navipro Knee Software Module, Kinamed, Inc. (2004) Summary page 1.

## Most influential descendants
- 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
- K203315: BLUEPRINT™ Patient Specific Instrumentation (2021), 18 descendants of its own

## Indications for use
The NaviPro TM Shoulder Software Module is a system for computer-aided navigation of surgical instruments whose purpose is to intra-operatively report the orientation of the glenoid and humeral components during shoulder replacement surgery. General spatial measurements may be made and recorded as deemed necessary by the surgeon user.

Source page: https://510kreport.com/device/K050897
Methodology: https://510kreport.com/methodology