# K140361: Meta-C Cervical Plate

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International
- Decided: Jun 12, 2014 after 120 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: 6 generations back to K953730 (1995). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 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 1.
- K001794: Ebi Anterior Cervical Plate System, Ebi, L.P. (2000) Summary page 1.
- K974706: Aesculap Abc Cervical Plating System, Aesculap, Inc. (1998) Summary page 1.
- K050451: Synthes Vectra System, Synthes Spine Co.Lp (2005) Summary page 1.
- K081038: Atlantis Anterior Cervical Plate System, Medtronic Sofamor Danek (2008) Summary page 1.

## Indications for use
The Mecta-C plate system is intended for anterior Interbody screw/plate fixation from C2 to Ti. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with; 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosisor scoliosis), 5) psuedarthrosis, and/or 6) failed previous fusion. This device system is intended for anterior cervical intervertebral body fusions only.

Source page: https://510kreport.com/device/K140361
Methodology: https://510kreport.com/methodology