# K051815: Modification to Vertebron SCP Cervical Plate System

- Pathway: 510(k) (Special)
- Applicant: Vertebron, Inc.
- Decided: Oct 17, 2005 after 104 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: 7 generations back to K922087 (1992). 29 ancestors in all.
10 later devices descend from it; 4 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982443: Doc Ventral Cervical Stabilization System, Depuy Motech Acromed (1998) Summary page 1.
- K973854: Orion Anterior Cervical Plate System, Sofamor Danek USA,Inc. (1998) Summary page 1.
- K971883: Synthes Spine Small Stature Anterior Cervical Vertebrae Plate System, Synthes (Usa) (1997) Summary page 1.
- K000536: Synthes Anterior CSLP System, Synthes Spine (2000) Summary page 1.
- K974706: Aesculap Abc Cervical Plating System, Aesculap, Inc. (1998) Summary page 2.
- K010003: Ebi Vuelock Anterior Cervical Plate System, Ebi, L.P. (2001) Summary page 2.
- K023133: Modification to Ebi Vuelock Anterior Cervical Plate System, Ebi, L.P. (2002) Summary page 2.
- K040003: Vertebron SCP Cervical Plate System, Vertebron, Inc. (2004) Summary page 1.
- K043181: Modification to Vertebron SCP Cervical Plate System, Vertebron, Inc. (2004) Summary page 1.

## Most influential descendants
- 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
- K180022: Athena Cervical Plate System (2018), 2 descendants of its own
- K091396: Cardo Medical Anterior Cervical Plate System (2009), 2 descendants of its own

## Indications for use
The VERTEBRON SCP TM 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 TM Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.

Source page: https://510kreport.com/device/K051815
Methodology: https://510kreport.com/methodology