# K181980: OsseoScrew System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Sep 25, 2018 after 62 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K040583 (2004). 114 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 116 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123623: Illico Mis Posterior Fixation System, Alphatec Spine, Inc. (2013) Summary page 4.
- K160879: CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems, Medos International Sàrl (2016) Summary page 4.

## Most influential descendants
- K202327: Invictus™ OsseoScrew® System (2020), 0 descendants of its own

## Indications for use
The OsseoScrew™ System (for use with the Zodiac™ Spinal Fixation System and Illico™ MIS Posterior Fixation System) is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

Source page: https://510kreport.com/device/K181980
Methodology: https://510kreport.com/methodology