# K032368: Sonoma Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Seaspine
- Decided: Oct 9, 2003 after 69 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
No predicates in its family tree.
19 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Synthes’ Synthes Anterior Cervical Vertebrae Plates: named in the summary without a submission number
- (no number) Howmedica Osteonics’ Reflex Anterior Cervical Plate System: named in the summary without a submission number

## Most influential descendants
- K083338: Cardiff Anterior Cervical Plate System (2009), 16 descendants of its own
- 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

## Indications for use
The Sonoma Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. This system is indicated for use in the temporary stabilization of the anterior spine from C2 to TI during the development of cervical spinal fusions in patients with: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (including fractures); primary and metastic malignant tumors; deformity (defined as kyphosis, lordosis, or scoliosis); pseudarthrosis; failed previous fusions; and/or spinal cord stenosis and cervical myelopathy.

Source page: https://510kreport.com/device/K032368
Methodology: https://510kreport.com/methodology