# K250486: Skyway Anterior Cervical Plate System

- Pathway: 510(k) (Special)
- Applicant: Kyocera Medical Technologies Inc. (KMTI)
- Decided: Apr 10, 2025 after 50 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: 27 generations back to K841189 (1984). 599 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 601 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243015: Skyway Anterior Cervical Plate System, Kyocera Medical Technologies, Inc. (2024) Summary page 6.

## Most influential descendants
- K261451: ZSAlign Cervical Interbody System (2026), 0 descendants of its own

## Indications for use
The Skyway Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis, or scoliosis), tumor, pseudarthrosis or failed previous fusion. The 4-Hole 1-Level Plates are limited to use at one contiguous level. The KMTI Tesera-k SC System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one or two levels from C2-T1. KMTI Tesera-k SC System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation. When used with the Skyway Anterior Cervical Plate System plates designed with spacer attachment, the assembly takes on the indications of the KMTI Tesera-k SC Interbody Spacer, with the Skyway Anterior Cervical Plate System acting as the supplemental fixation.

Source page: https://510kreport.com/device/K250486
Methodology: https://510kreport.com/methodology