# K121936: Naviopfs

- Pathway: 510(k) (Traditional)
- Applicant: Blue Belt Technologies, Inc.
- Decided: Nov 30, 2012 after 151 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K905070 (1991). 38 ancestors in all.
22 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)
- K081867: Mako Surgical Tactile Guidance System Version 2.0, Mako Surgical Corp. (2008) Summary page 1.
- K071714: Navitrack System - OS Unicondylar Knee Universal, Model#  Pro-06003, Orthosoft, Inc. (2007) Summary page 3.

## Most influential descendants
- K140596: NAVIO (2014), 21 descendants of its own
- K143668: Navio (2015), 20 descendants of its own
- K152574: Navio (2015), 19 descendants of its own
- K160537: Navio (2016), 18 descendants of its own
- K170360: NAVIO (2017), 17 descendants of its own

## Recalls of this device
- Feb 27, 2020 · Class II · Z-1634-2020: Potential for the NAVIO Soft Tissue Protector to become stuck or bound to the bone pin intraoperatively when inserting the NAVIO bone pins.
- Apr 11, 2014 · Class II · Z-1575-2014: Blue Belt Technologies is conducting a voluntary recall for their Navio PFS system which is used during orthopedic knee surgery. One of the electronic modules inside the computer cart assembly may hav

## Indications for use
The NavioPF STM 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 NavioPFSTM 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.

Source page: https://510kreport.com/device/K121936
Methodology: https://510kreport.com/methodology