# K180814: CoreLink® M3™ Stand-Alone Anterior Lumbar System

- Pathway: 510(k) (Traditional)
- Applicant: Corelink, LLC
- Decided: Aug 10, 2018 after 134 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, 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). 201 ancestors in all.
18 later devices descend from it; 6 cite it directly.
0 of 220 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151214: ALIF Interfixated System, Nu Vasive, Incorporated (2015) Summary page 5.
- K111626: Endoskeleton (R) Tas, Titan Spine, LLC (2011) Summary page 5.
- K142095: Renovis S134 Anterior Lumbar Interbody Fusion (Alif) System, Renovis Surgical Technologies, Inc. (2014) Summary page 5.
- K150847: Foundation Interbody Devices, Corelink, LLC (2015) Summary page 5.
- K162496: Foundation 3D Interbody, Corelink, LLC (2017) Summary page 5.

## Most influential descendants
- K192492: EL CAPITAN Anterior Lumber Interbody System (2020), 10 descendants of its own
- K222554: EL CAPITAN Anterior Lumbar Interbody Fusion (2023), 5 descendants of its own
- K214047: EL CAPITAN Anterior Lumbar Interbody Fusion System (2022), 3 descendants of its own
- K240126: ProAM ALIF System (2024), 2 descendants of its own
- K230731: Zavation ALIF System (2023), 2 descendants of its own

## Indications for use
The CoreLink® M3™ Stand-Alone Anterior Lumbar System is a standalone interbody fusion system indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The device may be used with supplemental fixation. Hyperlordotic implants (>20° lordosis) must be used with supplemental fixation (e.g. posterior fixation) that are cleared by the FDA for use in the lumbar spine. The system is indicated to be used with autograft bone. Patients should have received 6 months of non- operative treatment prior to treatment with the devices. The implants are intended to be used with the bone screws and lock provided. The system is designed to be a 3-screw implant, and all three (3) screws must be used. The accompanying lock must be used anytime the device is used with any number of screws. If the physician chooses to use less than the recommended number, then additional supplemental fixation in the lumbar spine must be used to augment fixation.

Source page: https://510kreport.com/device/K180814
Methodology: https://510kreport.com/methodology