# K212088: Integrity Implants Navigated Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Integrity Implants, Inc.
- Decided: Dec 23, 2021 after 170 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: 21 generations back to K040583 (2004). 367 ancestors in all.
No later device cites it as a predicate yet.
1 of 368 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140454: Navigated CD Horizon Solera Screwdriver/Taps, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 4.
- K190360: LineSider™ Spinal System, Integrity Implants, Inc. (2019) Summary page 4.
- K203367: LineSider™ Spinal System, Integrity Implants, Inc. (2020) Summary page 4.

## Indications for use
Integrity Implants Navigated Instruments are intended to be used during the preparation and placement of Integrity Implants spinal implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Integrity Implants Navigated Instruments are specifically designed for use with Medtronic’s 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.

Source page: https://510kreport.com/device/K212088
Methodology: https://510kreport.com/methodology