# K241082: INNOVERSE Navigation Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Innosys Co., Ltd.
- Decided: Jun 14, 2024 after 56 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: 31 generations back to K841189 (1984). 832 ancestors in all.
No later device cites it as a predicate yet.
1 of 833 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223494: CD Horizon Spinal System, Medtronic (2023) Summary page 5.

## Indications for use
INNOVERSE Navigation Instruments are intended to be used during the preparation and placement of INNOVERSE Spinal System implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in spinal procedures. These instruments are designed for use with the stereotactic navigation system Medtronic StealthStation™, 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 of the anatomy.

Source page: https://510kreport.com/device/K241082
Methodology: https://510kreport.com/methodology