# K201587: icotec Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Icotec AG
- Decided: Oct 15, 2020 after 126 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K922087 (1992). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050813: Abc 2 Screw, Aesculap, Inc. (2005) Summary page 5.
- K023133: Modification to Ebi Vuelock Anterior Cervical Plate System, Ebi, L.P. (2002) Summary page 5.
- K030866: Synthes Anterior CSLP System, Synthes (Usa) (2003) Summary page 5.

## Most influential descendants
- K233215: icotec Anterior Cervical Plate System (2024), 0 descendants of its own

## Indications for use
The icotec Anterior Cervical Plate 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 cervical spine (C2-T1) in whom life expectancy is of insufficient duration to permit achievement of fusion.

Source page: https://510kreport.com/device/K201587
Methodology: https://510kreport.com/methodology