# K173099: Fortis and Hana Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Huvexel Co., Ltd.
- Decided: Nov 30, 2017 after 62 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: 5 generations back to K973854 (1998). 21 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121862: Rex Anterior Cervical Plate System, Dio Medical Co., Ltd. (2012) Summary page 5.
- K081391: Vip Anterior Cervical Plate System, Globus Medical, Inc. (2008) Summary page 5.
- K000742: Synthes Anterior CSLP System, Synthes Spine (2000) Summary page 5.
- K001794: Ebi Anterior Cervical Plate System, Ebi, L.P. (2000) Summary page 5.
- K974706: Aesculap Abc Cervical Plating System, Aesculap, Inc. (1998) Summary page 5.

## Most influential descendants
- K222572: FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System (2022), 2 descendants of its own
- K250446: Frida™ Anterior Cervical Plate System (2025), 0 descendants of its own
- K231460: FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System, and Osprey™ Anterior Cervical Plate System (2023), 0 descendants of its own
- K220379: IMPEACE and IMPEACE-Uni Anterior Cervical Plate System (2022), 0 descendants of its own

## Indications for use
The FORTIS and HANA Anterior Cervical Plate System is intended for anterior fixation to the cervical spine C2-C7. The specific clinical indications include: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Source page: https://510kreport.com/device/K173099
Methodology: https://510kreport.com/methodology