# K243258: Paradigm System

- Pathway: 510(k) (Traditional)
- Applicant: Proprio, Inc.
- Decided: Feb 21, 2025 after 129 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: 4 generations back to K050438 (2005). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222291: Paradigm System, Proprio, Inc. (2023) Summary page 5.

## Most influential descendants
- K250879: Paradigm System (2025), 1 descendant of its own
- K252950: Paradigm System (2025), 0 descendants of its own

## Indications for use
The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons during open surgical procedures with appropriate bone preparation. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure that can be identified on CT derived patient images for pedicle screw cannulation of the thoracic to sacrum vertebrae.

Source page: https://510kreport.com/device/K243258
Methodology: https://510kreport.com/methodology