# K112861: Sintea Plustek Anterior Cervical Plate System

- Pathway: 510(k) (Special)
- Applicant: Sintea Plustek, LLC
- Decided: Feb 24, 2012 after 147 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: 4 generations back to K953730 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041989: Sintea Biotech Anterior Plate System, Model Acp.XX.T5.X, Sintea Biotech, Inc. (2004) Summary page 2.
- K000536: Synthes Anterior CSLP System, Synthes Spine (2000) Summary page 2.
- K103491: Skyline Anterior Cervical Plate System, A Johnson & Johnson Company (2011) Summary page 2.

## Indications for use
The Sintea Plustek Anterior Cervical Plate systems in indicated for use in the cervical spine (C3-C7) for the following conditions: * Degenerative Disc Disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) * Spondylolisthesis * Trauma (fracture or dislocation) * Spinal stenosis * Deformities or curvatures (scoliosis, kyphosis, lordosis) * Tumor * Pseudarthrosis * Failed previous fusion

Source page: https://510kreport.com/device/K112861
Methodology: https://510kreport.com/methodology