# K083338: Cardiff Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Seaspine, Inc.
- Decided: Feb 2, 2009 after 82 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 K926453 (1993). 6 ancestors in all.
16 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)
- K032368: Sonoma Anterior Cervical Plate System, Seaspine (2003) Summary page 1.
- K974885: Blackstone Medical Inc. Anterior Cervical Plate System, Blackstone Medical, Inc. (1998) Summary page 2.
- K994239: Zephir Anterior Cervical Plate System, Medtronic Sofamor Danek, Inc. (2000) Summary page 2.
- K926453: Synthes (U.S.a.) Anterior Cervical Vertebrae Plate, Synthes (Usa) (1993) Summary page 2.
- K945700: Synthes (Usa) Anterior Cervical Vertebrae Plate System, Synthes (Usa) (1995) Summary page 2.
- K000536: Synthes Anterior CSLP System, Synthes Spine (2000) Summary page 2.

## Most influential descendants
- K112206: Cardiff Anterior Cervical Plate System (2012), 15 descendants of its own
- 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

## 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 lordosis), * tumor, * pseudoarthrosis, and/or * failed previous fusion.

Source page: https://510kreport.com/device/K083338
Methodology: https://510kreport.com/methodology