# K163104: Terrace™ Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Corelink, LLC
- Decided: Jun 21, 2017 after 226 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). 66 ancestors in all.
18 later devices descend from it; 3 cite it directly.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121514: Anodyne Anterior Cervical Plate System, Corelink, LLC (2012) Summary page 4.
- K102820: Appliance, Fixation, Spinal Intervertebral Body, Alphatec Spine, Inc. (2010) Summary page 4.
- K100614: Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical Plates, Blackstone Medical, Inc. (2010) Summary page 4.
- K130202: Iris Anterior Cervical Plate, Life Spine, Inc. (2013) Summary page 4.
- K133475: Struxxure Anterior Cervical Plate and Screws, Nexxt Spine, LLC (2013) Summary page 4.

## Most influential descendants
- 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
- K231739: Cervical Spine Truss System (CSTS) (2023), 2 descendants of its own

## Indications for use
The CoreLink TERRACE™ 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 (DDD 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 – T1.

Source page: https://510kreport.com/device/K163104
Methodology: https://510kreport.com/methodology