# K180556: Corelink Foundation 3D Anterior Lumbar System

- Pathway: 510(k) (Special)
- Applicant: Corelink, LLC
- Decided: Jul 27, 2018 after 148 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.
5 later devices descend from it; 3 cite it directly.
0 of 176 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
- K220523: restor3d TiDAL Lumbar Interbody Fusion Device (2022), 2 descendants of its own
- K234087: restor3d TIDAL Lumbar Interbody Fusion System (2024), 0 descendants of its own
- K230329: F3D Interbody System (2023), 0 descendants of its own
- K223326: Axiom PSR System (2023), 0 descendants of its own
- K201939: GAIA Lumbar Interbody Fusion Device (LIFD) Family (2020), 0 descendants of its own

## Indications for use
Foundation 3D cervical implants are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Foundation cervical implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at one disc level (C2-T1) using autograft bone. Foundation 3D Interbody implants are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. Foundation 3D lumbar implants are 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 L2-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 nonoperative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K180556
Methodology: https://510kreport.com/methodology