# K040003: Vertebron SCP Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Vertebron, Inc.
- Decided: Mar 26, 2004 after 84 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 K922087 (1992). 21 ancestors in all.
12 later devices descend from it; 6 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022344: Trinica Select Anterior Cervical Plate System, Centerpulse Spine-Tech, Inc. (2002) Summary page 1.
- K010466: Tether Acfs, Theken Surgical,Llc (2001) Summary page 1.
- K030595: Blackstone Fusion Anterior Cervical Plating System, Blackstone Medical, Inc. (2003) Summary page 1.

## Most influential descendants
- K043181: Modification to Vertebron SCP Cervical Plate System (2004), 11 descendants of its own
- K051815: Modification to Vertebron SCP Cervical Plate System (2005), 10 descendants of its own
- K062110: Vertebron SCP Cervical Plate System (2006), 9 descendants of its own
- K081567: Vertebron SSP Cervical Plating System (2008), 6 descendants of its own
- K073530: Accin Anterior Cervical Plate System (2008), 3 descendants of its own

## Indications for use
The Vertebron SCPTM Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine 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), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthriosis, and/or failed previous fusions. The SCP Cervical Plate System can be implanted in the sub-axial cervical spine from the C3 through C7 levels.

Source page: https://510kreport.com/device/K040003
Methodology: https://510kreport.com/methodology