# K121514: Anodyne Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Corelink, LLC
- Decided: Dec 14, 2012 after 206 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: 4 generations back to K971730 (1997). 18 ancestors in all.
21 later devices descend from it; 2 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)
- K993855: Atlantis Anterior Cervical Plate System, Danek Medical, Inc. (1999) Summary page 2.
- K042235: Orion Anterior Cervical Plating System, Medtronic Sofamor Danek (2004) Summary page 2.
- K000742: Synthes Anterior CSLP System, Synthes Spine (2000) Summary page 2.
- K010466: Tether Acfs, Theken Surgical,Llc (2001) Summary page 2.
- K982443: Doc Ventral Cervical Stabilization System, Depuy Motech Acromed (1998) Summary page 2.
- K100070: Uniplate Anterior Cervical Plate System, Depuy Spine, Inc. (2010) Summary page 2.
- K082273: Uniplate Anterior Cervical Plate System, Depuy Spine, Inc. (2008) Summary page 2.
- K042544: Uniplate Anterior Cervical Plate System, Depuy Spine, Inc. (2004) Summary page 2.

## Most influential descendants
- K163104: Terrace™ Anterior Cervical Plate System (2017), 18 descendants of its own
- K190016: Lateral Plate System (2019), 15 descendants of its own
- K203065: Lumbar Spine Truss System Plating Solution (LSTS-PS) (2021), 9 descendants of its own
- K231743: F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System (2023), 3 descendants of its own
- K223362: Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device (2023), 3 descendants of its own

## Indications for use
The CoreLink ANODYNES Anterior Cervical Plate System is intended for anterior fixation of the cervical spine. Indications for use include the temporary stabilization of the anterior spine during the evolution of cervical fusions in patients with degenerative disc disease (ODD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions. The intended levels for treatment range from C2 - T I.

Source page: https://510kreport.com/device/K121514
Methodology: https://510kreport.com/methodology