# K171112: Trifore (tm) Cervical Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Neurostructures, Inc.
- Decided: Jun 8, 2017 after 55 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: 8 generations back to K922087 (1992). 29 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142060: Transom Anterior Cervical Plate, Neurostructures, Inc. (2014) Summary page 6.
- K120515: Tempus Cervical Plate System, Neurostructures, LLC (2012) Summary page 6.
- K131374: Tempus (TM) Cervical Plate System, Neurostructures, LLC (2013) Summary page 6.
- K030866: Synthes Anterior CSLP System, Synthes (Usa) (2003) Summary page 6.

## Most influential descendants
- K193494: Origin™ Anterior Cervical Plate System (2020), 0 descendants of its own

## Indications for use
The Trifore™ Cervical Plating System is intended for anterior cervical fixation (C2-T1) 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/K171112
Methodology: https://510kreport.com/methodology