# K192495: Black Diamond Navigation Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Osseus Fusion Systems
- Decided: Jan 17, 2020 after 128 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: 12 generations back to K862807 (1986). 80 ancestors in all.
No later device cites it as a predicate yet.
1 of 81 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.
- K140927: Universal Navigation Instruments, Medos International SARL (2014) Summary page 4.
- K172517: SeaSpine Navigation System, SeaSpine Orthopedics Corporation (2018) Summary page 4.

## Indications for use
The Black Diamond Navigation Instruments are intended to be used during the preparation and placement of Black Diamond pedicle screws during spinal surgery to aid the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Black Diamond Navigation Instruments 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 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/K192495
Methodology: https://510kreport.com/methodology