# K181606: Precision Spine Navigation Instrumentation

- Pathway: 510(k) (Traditional)
- Applicant: Precision Spine, Inc.
- Decided: Sep 27, 2019 after 465 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 K862807 (1986). 64 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153603: Alphatec Navigation Instruments, Alphatec Spine, Inc. (2016) Summary page 5.
- K140454: Navigated CD Horizon Solera Screwdriver/Taps, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 5.

## Most influential descendants
- K252962: DYNAMIS™ Navigation System (2026), 0 descendants of its own
- K240963: Spinal System (2024), 0 descendants of its own
- K231229: S-COMP Reform® POCT Navigation Instruments (2023), 0 descendants of its own

## Indications for use
Precision Spine Navigation Instrumentation are intended to be used during the preparation and placement of Precision Spine screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Precision Spine Navigation Instrumentation are specifically designed for use with the Medtronic Stealth Station 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 skull, a long bone, or 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/K181606
Methodology: https://510kreport.com/methodology