# K140454: Navigated CD Horizon Solera Screwdriver/Taps

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: May 22, 2014 after 87 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: 9 generations back to K862807 (1986). 62 ancestors in all.
396 later devices descend from it; 49 cite it directly.
1 of 459 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K124004: Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps, Medtronic Navigation, Inc. (2013) Summary page 2.
- K111520: Ipc Powerease System, Medtronic Xomed, Inc. (2011) Summary page 2.
- K123270: Powerease System, Medtronic Sofamor Danek USA, Inc. (2013) Summary page 2.

## Most influential descendants
- 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
- K153203: Navigation Instruments (2016), 112 descendants of its own
- K163581: Navigated ELEVATE Inserter, Navigated Disc Prep Instruments (2017), 103 descendants of its own

## Recalls of this device
- Jul 12, 2023 · Class II · Z-2363-2023: Incorrect Laser Marking - Solera Awl Tip Tap

## 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®E 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®)POWEREASETM System.

Source page: https://510kreport.com/device/K140454
Methodology: https://510kreport.com/methodology