# K193494: Origin™ Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Orthopaedic & Spine Development
- Decided: Apr 6, 2020 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: 9 generations back to K922087 (1992). 74 ancestors in all.
No later device cites it as a predicate yet.
0 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171112: Trifore (tm) Cervical Plating System, Neurostructures, Inc. (2017) Summary page 4.
- K163104: Terrace™ Anterior Cervical Plate System, Corelink, LLC (2017) Summary page 4.

## Indications for use
The Origin Anterior 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 or radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvature (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Source page: https://510kreport.com/device/K193494
Methodology: https://510kreport.com/methodology