# K223494: CD Horizon Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic
- Decided: Jan 23, 2023 after 63 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 30 generations back to K841189 (1984). 831 ancestors in all.
17 later devices descend from it; 9 cite it directly.
1 of 849 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221244: CD Horizon™ Spinal System, Medtronic (2022) Summary page 6.
- K221646: CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™ SPINAL SYSTEM; CD Horizon™ Fenestrated Screw Set; COLORADO 2™ SPINAL System; GDLH™ POSTERIOR SPINAL SYSTEM; SHILLA™ Growth Guidance System; TENOR™ SPINAL SYSTEM, Medtronic Sofamor Danek USA, Inc. (2022) Summary page 6.
- K162379: CD HORIZON® Spinal System, Medtronic Sofamor Danek USA, Inc. (2016) Summary page 6.
- K113174: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2011) Summary page 6.
- K214010: Anteralign Spinal System with Titan nanoLOCK Surface Technology, Medtronic Sofamor Danek USA (2022) Summary page 6.
- K210637: CD Horizon™ Spinal System, Medtronic (2021) Summary page 6.
- K201407: CD Horizon™ Spinal System, Medtronic Sofamor Danek USA, Inc. (2020) Summary page 6.
- K042025: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek, Inc. (2004) Summary page 6.

## Most influential descendants
- K233951: CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) (2024), 5 descendants of its own
- K233508: iFuse Bedrock Granite® Implant System (2024), 5 descendants of its own
- K243007: CD Horizon™ Spinal System (2024), 3 descendants of its own
- K253802: KHEIRON® Spinal Fixation System, including patient specific K-ROD (2026), 1 descendant of its own
- K241464: ARx® SAI Implant System (2024), 1 descendant of its own

## Indications for use
Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Navigated Reusable Instruments are specifically designed for use with the 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 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 Navigated Reusable Instruments are also compatible with the IPC™ Powerease™ System. The IPC™ System is indicated for the incision/cutting, removal, drilling and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures. The IPC™ Powerease™ System is indicated for drilling, tapping, and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. It is also used in placement or cutting of screws, posts, and rods.

Source page: https://510kreport.com/device/K223494
Methodology: https://510kreport.com/methodology