# K163581: Navigated ELEVATE Inserter, Navigated Disc Prep Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Apr 14, 2017 after 115 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: 16 generations back to K003155 (2001). 198 ancestors in all.
103 later devices descend from it; 3 cite it directly.
1 of 302 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150231: Navigated Disc Prep Instruments and CAPSTONE Trials, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 4.
- K131425: Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale Inserter, Medtronic Navigation, Inc. (2013) Summary page 4.
- K142559: ELEVATE Spinal System, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 4.

## Most influential descendants
- K210425: Catalyft PL Expandable Interbody System (2021), 56 descendants of its own
- K212524: Anteralign Spinal System with Titan nanoLOCK Surface Technology (2021), 55 descendants of its own
- K214010: Anteralign Spinal System with Titan nanoLOCK Surface Technology (2022), 49 descendants of its own
- K191100: ExcelsiusGPS Spine 1.1 Interbody Module (2019), 42 descendants of its own
- K222028: IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System (2022), 28 descendants of its own

## Indications for use
The Navigated Disc Preparation Instruments are intended to be used to facilitate a discectomy during spinal surgery. The Navigated CAPSTONE™ Trials are intended to be used to facilitate implant size selection of Medtronic intervertebral body fusion devices during spinal surgery. When the Navigated Rotating Shavers are used as trials for ELEVATE™ Spinal System, they are intended to be used to facilitate implant size selection. The Navigated Probe is intended to be used during pedicle and disc preparation during spinal fusion procedures. The Navigated Inserters are intended to be used for the placement of an implant. Navigated 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.

Source page: https://510kreport.com/device/K163581
Methodology: https://510kreport.com/methodology