# K190016: Lateral Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Corelink, LLC
- Decided: Jun 12, 2019 after 160 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: 9 generations back to K990745 (1999). 131 ancestors in all.
15 later devices descend from it; 3 cite it directly.
0 of 147 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120092: Plymouth Thoracolumbar Plate System, Globus Medical, Inc. (2012) Summary page 5.
- K131533: Cayman MI Plate System, K2m, Inc. (2013) Summary page 5.
- K150449: LITe Plate System, Stryker Corp. (2015) Summary page 5.
- K091044: Spinal Usa Anterior Lumbar Plate System, Spinal USA (2009) Summary page 5.
- K082187: Biomet Anterior Lumbar Plate, Ebi, L.P. (2008) Summary page 5.
- K111866: Nuvasive Anterior Lumbar Plate System, Nuvasive, Inc. (2011) Summary page 5.
- K163104: Terrace™ Anterior Cervical Plate System, Corelink, LLC (2017) Summary page 5.

## Most influential descendants
- 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
- K241487: Interwedge® Standalone Lateral (2024), 1 descendant of its own

## Indications for use
The CoreLink Lateral Plate System (LPS) is intended for use as a laterally placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The CoreLink LPS is designed to provide temporary stability until fusion is achieved. It is intended for lateral or anterolateral lumbar (L1-S1) fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion. Alternatively, the CoreLink LPS may remain attached to CoreLink Lateral lumbar interbody devices after implantation. In this configuration the CoreLink LPS must only be used to treat patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels.

Source page: https://510kreport.com/device/K190016
Methodology: https://510kreport.com/methodology