# K243073: AnyPlus Navigated Instruments System

- Pathway: 510(k) (Traditional)
- Applicant: GS Medical Co., Ltd.
- Decided: Dec 6, 2024 after 70 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: 10 generations back to K862807 (1986). 76 ancestors in all.
No later device cites it as a predicate yet.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091717: Any Plus Spinal Fixation System, GS Medical Co., Ltd. (2010) Summary page 6.
- K140454: Navigated CD Horizon Solera Screwdriver/Taps, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 6.

## Indications for use
The AnyPlus Navigated Instrument System is indicated for the preparation and placement of the Poly-Axial Screws of the AnyPlus Spinal Fixation System during a navigated thoracolumbar fusion procedure to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. This system is intended to be used in conjunction 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. The use of the AnyPlus Navigated Instrument system is limited to use only with the AnyPlus Spinal Fixation System.

Source page: https://510kreport.com/device/K243073
Methodology: https://510kreport.com/methodology