# K041989: Sintea Biotech Anterior Plate System, Model Acp.XX.T5.X

- Pathway: 510(k) (Traditional)
- Applicant: Sintea Biotech, Inc.
- Decided: Sep 16, 2004 after 55 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 K000536 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000742: Synthes Anterior CSLP System, Synthes Spine (2000) Summary page 2.
- K000536: Synthes Anterior CSLP System, Synthes Spine (2000) Summary page 2.

## Most influential descendants
- K112861: Sintea Plustek Anterior Cervical Plate System (2012), 0 descendants of its own

## Indications for use
The Sintea Biotech Anterior Cervical Plate System is indicated for use in the cervical spine (levels C3 to C7) in 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 curvature (scoliosis, kyphosis, lordosis) * Tumor * Pseudarthrosis * Failed previous fusion

Source page: https://510kreport.com/device/K041989
Methodology: https://510kreport.com/methodology