# K250520: OsteoCentric Navigated Instruments System

- Pathway: 510(k) (Traditional)
- Applicant: Osteocentric Technologies, Inc.
- Decided: Oct 27, 2025 after 248 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: 18 generations back to K040583 (2004). 351 ancestors in all.
No later device cites it as a predicate yet.
0 of 352 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170679: CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems, Medtronic Sofamor Danek (2017) Summary page 6.
- K140454: Navigated CD Horizon Solera Screwdriver/Taps, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 6.
- K173338: Navigated INFINITY™ Instruments, Medtronic Sofamor Danek USA, Inc. (2018) Summary page 6.
- K221332: OsteoCentric Spine MIS Pedicle Fastener System, OsteoCentric Technologies (2022) Summary page 6.

## Indications for use
The OsteoCentric Navigated Instruments are intended to be used during the preparation and placement of OsteoCentric Pedicle Fasteners during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. The OsteoCentric Navigated Instruments are specifically designed for use with the Medtronic StealthStation@ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

Source page: https://510kreport.com/device/K250520
Methodology: https://510kreport.com/methodology