# K203816: DeGen Navigated Instrumentation

- Pathway: 510(k) (Traditional)
- Applicant: Degen Medical
- Decided: Apr 2, 2021 after 94 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: 17 generations back to K040583 (2004). 153 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 155 devices in its family (counting itself) have 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.
- K172166: OLYMPIC Navigated Instruments, Astura Medical (2018) Summary page 4.

## Most influential descendants
- K213918: DeGen Navigated Instrumentation (2022), 0 descendants of its own

## Indications for use
The DeGen Medical Navigated Instrumentation is intended to be used during the preparation and placement of DeGen Medical F1 MPS and E3 MIS screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. DeGen Medical Navigated Instrumentation is specifically designed for use 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 ofthe anatomy.

Source page: https://510kreport.com/device/K203816
Methodology: https://510kreport.com/methodology