# K231743: F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Corelink, LLC
- Decided: Dec 8, 2023 after 177 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: 26 generations back to K841189 (1984). 455 ancestors in all.
3 later devices descend from it; 2 cite it directly.
1 of 459 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192006: SIRION Lateral Lumbar Interbody System, Astura Medical, LLC (2020) Summary page 6.
- K202495: SIRION Lateral Lumbar Interbody Fusion, Astura Medical, LLC (2021) Summary page 6.
- K183239: CoreLink F3D™ Lateral System, Corelink, LLC (2018) Summary page 5.
- K150847: Foundation Interbody Devices, Corelink, LLC (2015) Summary page 5.
- K190016: Lateral Plate System, Corelink, LLC (2019) Summary page 5.

## Most influential descendants
- 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 Lumbar Interbody 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 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 | spondylolisthesis or retrolisthesis at the involved level(s). F3D Lateral Lumbar 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. Hyperlordotic interbody devices (220° lordosis) must be used in conjunction with the Oro Lateral plate for fixation. If using the 1-hole CorelLink Oro Lateral Plate System, additional supplemental fixation is required (e.g. posterior fixation). The CL5 Lumbar Cage 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 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 | spondylolisthesis or retrolisthesis at the involved level(s). CLS Lumbar 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. The CorelLink Oro Lateral Plate System (LPS), in two and four-hole configurations, 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 Oro Lateral Plate System 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, pseudarthrosis, and failed previous fusion. Alternatively, the CoreLink Oro Lateral Plate System may remain attached to CoreLink Lateral lumbar interbody devices after implantation. In this configuration the CoreLink Oro 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. The CoreLink Oro LPS, one-hole configuration is intended for use in conjunction with traditional supplemental fixation to maintain the relative position of interbody spacers during spinal fusion. The one-hole plate is not intended for use in load-bearing applications. Hyperlordotic interbody devices (220° lordosis) must be used in conjunction with the CoreLink Oro Lateral Plate System (LPS) for fixation.

Source page: https://510kreport.com/device/K231743
Methodology: https://510kreport.com/methodology