# K143668: Navio

- Pathway: 510(k) (Traditional)
- Applicant: Blue Belt Technologies, Inc.
- Decided: Mar 20, 2015 after 86 days
- Product code: OLO (Orthopedic 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: 11 generations back to K905070 (1991). 40 ancestors in all.
20 later devices descend from it; 1 cites it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140596: NAVIO, Blue Belt Technologies, Inc. (2014) Summary page 4.

## Most influential descendants
- K152574: Navio (2015), 19 descendants of its own
- K160537: Navio (2016), 18 descendants of its own
- K170360: NAVIO (2017), 17 descendants of its own
- K180271: NAVIO™ Surgical System (NAVIO system) (2018), 16 descendants of its own
- K191223: NAVIO (2019), 15 descendants of its own

## Indications for use
The Navio system is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The Navio system is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined. These procedures include unicondylar knee replacement and patellofemoral arthroplasty. The Navio system is indicated for use with cemented implants only.

Source page: https://510kreport.com/device/K143668
Methodology: https://510kreport.com/methodology