# K183239: CoreLink F3D™ Lateral System

- Pathway: 510(k) (Special)
- Applicant: Corelink, LLC
- Decided: Dec 19, 2018 after 29 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K841189 (1984). 170 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 179 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162496: Foundation 3D Interbody, Corelink, LLC (2017) Summary page 4.
- K150847: Foundation Interbody Devices, Corelink, LLC (2015) Summary page 4.

## Most influential descendants
- K231743: F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System (2023), 3 descendants of its own
- K220523: restor3d TiDAL Lumbar Interbody Fusion Device (2022), 2 descendants of its own
- K241487: Interwedge® Standalone Lateral (2024), 1 descendant of its own
- K261809: Interwedge® Standalone Lateral (2026), 0 descendants of its own
- K232256: Alcantara Thoracolumbar Plate System (2024), 0 descendants of its own

## Indications for use
The F3D™ Lateral System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L.2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Foundation™ implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non- operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K183239
Methodology: https://510kreport.com/methodology