# K112206: Cardiff Anterior Cervical Plate System

- Pathway: 510(k) (Special)
- Applicant: Seaspine, Inc.
- Decided: Jan 25, 2012 after 177 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: 2 generations back to K926453 (1993). 7 ancestors in all.
15 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083338: Cardiff Anterior Cervical Plate System, Seaspine, Inc. (2009) Summary page 1.
- K032368: Sonoma Anterior Cervical Plate System, Seaspine (2003) Summary page 1.

## Most influential descendants
- K202064: Admiral ACP System (2020), 14 descendants of its own
- K211903: Shoreline Threaded TruProfile® Plate (2021), 7 descendants of its own
- K212139: Admiral ACP System (2021), 6 descendants of its own
- K233640: Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody System (2024), 5 descendants of its own
- K252611: aprevo® cervical plating system (2025), 3 descendants of its own

## Indications for use
This system is indicated for use in the temporary stabilization of the anterior spine from C2 to C7 during the development of cervical spinal fusions in patients with: * degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, * trauma (including fracture or dislocation), * spinal stenosis, * cervical myelopathy, * deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordlosis), * tumor, * pseudloarthrosis, and/or * failed previous fusion.

Source page: https://510kreport.com/device/K112206
Methodology: https://510kreport.com/methodology