# K153603: Alphatec Navigation Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Apr 29, 2016 after 134 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: 10 generations back to K862807 (1986). 63 ancestors in all.
79 later devices descend from it; 5 cite it directly.
0 of 143 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140454: Navigated CD Horizon Solera Screwdriver/Taps, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 4.

## Most influential descendants
- K172517: SeaSpine Navigation System (2018), 60 descendants of its own
- 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

## Indications for use
Alphatec Spine Navigated Reusable Instruments are intended to be used during the preparation and placement of Alphatec screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Alphatec Spine Navigated Reusable Instruments are specifically designed for use with the Medtronic 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, along 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/K153603
Methodology: https://510kreport.com/methodology