# K182121: CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Nov 2, 2018 after 88 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: 10 generations back to K862807 (1986). 63 ancestors in all.
41 later devices descend from it; 5 cite it directly.
0 of 105 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.

## Most influential descendants
- K203291: CD Horizon Spinal System Instruments (2020), 35 descendants of its own
- K210637: CD Horizon™ Spinal System (2021), 34 descendants of its own
- K221244: CD Horizon™ Spinal System (2022), 20 descendants of its own
- K223494: CD Horizon Spinal System (2023), 17 descendants of its own
- K211958: CD Horizon Spinal System (2021), 15 descendants of its own

## Indications for use
Medtronic Surgical Instruments are intended to be used during the 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 Surgical Instruments are specifically designed for use with the MAZOR X Stealth™ Edition, 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, a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Surgical Instruments can be navigated or non-navigated manual instruments that may or may not be guided through the MAZOR X Arm Guide. Medtronic surgical drills shall only be used through the MAZOR X arm guides, Medtronic cannulas, and Medtronic drill guides. Some of the Medtronic Surgical Instruments are also compatible with the IPC™ POWEREASE™ System. An instrument may incorporate a measuring function which has uses as described on the label and the instrument. DO NOT IMPLANT THE INSTRUMENTS

Source page: https://510kreport.com/device/K182121
Methodology: https://510kreport.com/methodology