# K042544: Uniplate Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Spine, Inc.
- Decided: Nov 23, 2004 after 64 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 K914362 (1992). 1 ancestor in all.
107 later devices descend from it; 26 cite it directly.
0 of 109 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914362: Top Cervical Spine Plates & Titanium Bone Screws, Acorn Group, Inc. (1992) Summary page 1.

## Most influential descendants
- K082273: Uniplate Anterior Cervical Plate System (2008), 50 descendants of its own
- K100070: Uniplate Anterior Cervical Plate System (2010), 47 descendants of its own
- K071667: Synthes Vectra-One System (2007), 26 descendants of its own
- K121514: Anodyne Anterior Cervical Plate System (2012), 21 descendants of its own
- K072703: Pioneer Slimfuse Anterior Cervical Plating System (2008), 19 descendants of its own

## Indications for use
The Uniplate Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1. Indication includes symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, re-operation for failed fusion, or instability following surgery for the above indications.

Source page: https://510kreport.com/device/K042544
Methodology: https://510kreport.com/methodology