# K221180: Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: May 25, 2022 after 30 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: 29 generations back to K841189 (1984). 597 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 600 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212524: Anteralign Spinal System with Titan nanoLOCK Surface Technology, Medtronic Sofamor Danek USA, Inc. (2021) Summary page 4.

## Most influential descendants
- K252742: Navigated Instruments (2025), 1 descendant of its own
- K261060: Navigated LLIF Impactable Tracker (2026), 0 descendants of its own

## Indications for use
Medtronic Navigated Surgical Instruments are intended to be used during preparation and placement of Medtronic implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Medtronic Navigated Reusable Instruments are compatible with various Medtronic spinal implant systems. Navigated surgical instruments are specifically designed for use with the 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 skull, long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. An instrument may incorporate a measuring function, which has uses described on the label and the instruments.

Source page: https://510kreport.com/device/K221180
Methodology: https://510kreport.com/methodology