# K202327: Invictus™ OsseoScrew® System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Oct 15, 2020 after 59 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: 27 generations back to K841189 (1984). 700 ancestors in all.
No later device cites it as a predicate yet.
2 of 701 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181980: OsseoScrew System, Alphatec Spine, Inc. (2018) Summary page 4.
- K181677: Kodiak Spinal Fixation System, Alphatec Spine, Inc. (2018) Summary page 4.
- K192938: Invictus™ Spinal Fixation System, Alphatec Spine, Inc. (2019) Summary page 4.
- K982320: Depuy Motech Moss Miami Spinal System, Depuy, Inc. (1998) Summary page 4.

## Indications for use
The Invictus™ OsseoScrew® System (for use with the Invictus™ Spinal Fixation System and the transition rods from the Invictus™ CT Spinal 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/K202327
Methodology: https://510kreport.com/methodology