# K151553: Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed Implantes, Ltda
- Decided: Feb 10, 2016 after 246 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: 5 generations back to K953730 (1995). 18 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031276: Synthes Anterior Cervical Locking Plate (Aclp) System, Synthes (Usa) (2003) Summary page 4.
- K030866: Synthes Anterior CSLP System, Synthes (Usa) (2003) Summary page 4.
- K000742: Synthes Anterior CSLP System, Synthes Spine (2000) Summary page 4.
- K000536: Synthes Anterior CSLP System, Synthes Spine (2000) Summary page 4.
- K945700: Synthes (Usa) Anterior Cervical Vertebrae Plate System, Synthes (Usa) (1995) Summary page 4.
- K080646: C-Tek Maxan Anterior Cervical Plate System, Biomet Spine (2008) Summary page 4.
- K042544: Uniplate Anterior Cervical Plate System, Depuy Spine, Inc. (2004) Summary page 4.
- K082273: Uniplate Anterior Cervical Plate System, Depuy Spine, Inc. (2008) Summary page 4.
- K100070: Uniplate Anterior Cervical Plate System, Depuy Spine, Inc. (2010) Summary page 4.

## Most influential descendants
- K161524: Tangis Anterior Cervical Plate (2016), 8 descendants of its own
- K210424: Quantum Anterior Cervical Plate (2021), 4 descendants of its own
- K252611: aprevo® cervical plating system (2025), 3 descendants of its own
- K260570: corra™ cervical plating system (2026), 1 descendant of its own
- K202657: Javelin Tailor's Bunion Fixation System (2020), 1 descendant of its own

## Indications for use
The Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion 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), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis

Source page: https://510kreport.com/device/K151553
Methodology: https://510kreport.com/methodology