# K172517: SeaSpine Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: SeaSpine Orthopedics Corporation
- Decided: May 11, 2018 after 263 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: 11 generations back to K862807 (1986). 65 ancestors in all.
60 later devices descend from it; 5 cite it directly.
0 of 126 devices in its family (counting itself) have 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 4.
- K140454: Navigated CD Horizon Solera Screwdriver/Taps, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 4.
- K143628: Navigated Vertex Select Instruments, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 4.
- K153603: Alphatec Navigation Instruments, Alphatec Spine, Inc. (2016) Summary page 4.

## Most influential descendants
- K191648: Mariner MIS Pedicle Screw System; SeaSpine Navigation System (2019), 49 descendants of its own
- K211606: Mariner Deformity System (2021), 47 descendants of its own
- K212692: Mariner Pedicle Screw System (2021), 46 descendants of its own
- K220195: iFuse Bedrock Granite™ Implant System (2022), 32 descendants of its own
- K222774: iFuse Bedrock Granite® Implant System (2022), 20 descendants of its own

## Recalls of this device
- Nov 17, 2025 · Class II · Z-0937-2026: The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic s Solera and Medtronic s Infinity system toolcards as compatible with the NorthStar OCT Navigation Ins

## Indications for use
The SeaSpine Navigation System reusable instruments are intended to be used during the preparation and placement of SeaSpine screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SeaSpine Navigation reusable instruments are specifically designed for use with the Medtronic Stealth Station 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 for the anatomy.

Source page: https://510kreport.com/device/K172517
Methodology: https://510kreport.com/methodology