# K124004: Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Navigation, Inc.
- Decided: Mar 22, 2013 after 86 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K862807 (1986). 60 ancestors in all.
404 later devices descend from it; 15 cite it directly.
1 of 465 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050438: Stealthstation System Update, Medtronic Surgical Navigation Technologies (2005) Summary page 2.
- K111520: Ipc Powerease System, Medtronic Xomed, Inc. (2011) Summary page 2.

## Most influential descendants
- K140454: Navigated CD Horizon Solera Screwdriver/Taps (2014), 396 descendants of its own
- K131425: Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale Inserter (2013), 246 descendants of its own
- K150231: Navigated Disc Prep Instruments and CAPSTONE Trials (2015), 242 descendants of its own
- K143375: CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments (2015), 207 descendants of its own
- K143628: Navigated Vertex Select Instruments (2015), 206 descendants of its own

## Recalls of this device
- Sep 14, 2015 · Class II · Z-2823-2015: Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking during surgery.

## Indications for use
The Navigated Taps and Screwdrivers are intended to be used during the preparation and placement of Medtronic screws during spinal surgery and are specifically designed for use with the Stealth Station® System, which is indicated for any medical condition in which the use of stereotactic surgery mnay be appropriate, and where reference to a rigid anatomical structure, such as the 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.

Source page: https://510kreport.com/device/K124004
Methodology: https://510kreport.com/methodology