# K203154: KASILOF Cervical Plate System

- Pathway: 510(k) (Special)
- Applicant: Kahtnu Surgical, Inc.
- Decided: Nov 5, 2020 after 14 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: 6 generations back to K031276 (2003). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173867: Axis Anterior Cervical Plate System, Axis Orthopaedics (2018) Summary page 5.
- K021461: Atlantis Vision Anterior Cervical Plate System, Medtronic Sofamor Danek (2002) Summary page 5.

## Indications for use
The KASILOF Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion from levels C2 through T1 of the cervical spine. The system is indicated for use in the stabilization of the anterior cervical spine during the development of cervical spinal fusion in patients. The indications include spinal stenosis, degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,), tumors, deformity (defined by kyphosis, lordosis, or scoliosis), and/or pseudarthrosis (defined as failed previous fusion).

Source page: https://510kreport.com/device/K203154
Methodology: https://510kreport.com/methodology