# DEN180012: LOADPRO™ Intraoperative Rod Strain Sensor

- Pathway: De Novo (Direct)
- Applicant: Intellirod Spine, Inc.
- Decided: Mar 28, 2019 after 379 days
- Product code: QFP (Intraoperative Orthopedic Strain Sensor)
- Device class: 2
- Regulation: 21 CFR 888.3090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The LOADPRO™ Intraoperative Rod Strain Sensor is an intraoperative surgical tool that allows surgeons to measure unidirectional rod microstrain on posterior rods in the sagittal plane when performing spine surgery. This device is an adjunct to surgeon tactile feedback and is not intended to replace a surgeon’s clinical judgment. The LOADPRO™ Intraoperative Rod Strain Sensor is a single use, disposable tool to be used in conjunction with X-Spine Systems Fortex Pedicle Screw System for 5.5mm diameter titanium (ASTM F136) or cobalt chrome (ASTM F1537) rod configurations.

Source page: https://510kreport.com/device/DEN180012
Methodology: https://510kreport.com/methodology