# K173935: Mediant Anterior Cervical Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Intelligent Implant Systems, LLC
- Decided: Apr 16, 2018 after 111 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: 1 generation back to K945700 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030866: Synthes Anterior CSLP System, Synthes (Usa) (2003) Summary page 4.
- K945700: Synthes (Usa) Anterior Cervical Vertebrae Plate System, Synthes (Usa) (1995) Summary page 4.
- K022997: Spectrum Cervical Spinal System, Spinal Innovations, LLC (2002) Summary page 4.

## Indications for use
The Intelligent Implant Systems Mediant™ Anterior Cervical Plating System is intended for anterior cervical fixation for the following indications: 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/K173935
Methodology: https://510kreport.com/methodology