# K200927: Transept Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Neurostructures, Inc.
- Decided: Jul 24, 2020 after 108 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). 57 ancestors in all.
No later device cites it as a predicate yet.
0 of 58 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 4.
- K131374: Tempus (TM) Cervical Plate System, Neurostructures, LLC (2013) Summary page 5.
- K120515: Tempus Cervical Plate System, Neurostructures, LLC (2012) Summary page 5.
- K133518: Maxan Anterior Cervical Plate System, Biomet Spine (Aka Ebi, LLC) (2014) Summary page 5.
- K111796: Invizia Anterior Cervical Plate System, Zimmer Spine, Inc. (2011) Summary page 5.
- K150666: uNion Cervical Plate System, Ulrich Medical USA (2015) Summary page 5.

## Indications for use
The Transept™ Cervical Plate 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/K200927
Methodology: https://510kreport.com/methodology