# K202495: SIRION Lateral Lumbar Interbody Fusion

- Pathway: 510(k) (Traditional)
- Applicant: Astura Medical, LLC
- Decided: Jan 6, 2021 after 128 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: 25 generations back to K841189 (1984). 324 ancestors in all.
6 later devices descend from it; 3 cite it directly.
1 of 331 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 4.
- K152512: Half Dome Posterior Lumbar Interbody System, Astura Medical (2016) Summary page 4.
- K163481: HALF DOME Posterior Lumbar Interbody System, Astura Medical (2017) Summary page 4.
- K172947: HALF DOME Posterior Lumbar Interbody System, Astura Medical (2018) Summary page 4.
- K182877: HALF DOME Posterior Lumbar Interbody System, Astura Medical, LLC (2019) Summary page 4.
- K182746: ATEC ALIF and LLIF Spacer System, Alphatec Spine, Inc. (2018) 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
- K241487: Interwedge® Standalone Lateral (2024), 1 descendant of its own
- K221806: TruLift Lateral Expandable Spacer System & Lateral Plate System (2022), 1 descendant of its own
- K261809: Interwedge® Standalone Lateral (2026), 0 descendants of its own
- K251502: TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System (2025), 0 descendants of its own

## Indications for use
The SIRION Lateral Lumbar Interbody System Spacer, either used individually or assembled to the SIRION plate, 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 L1-L2 to L5-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). SIRION Spacers are to be used with autogenous bone graft and supplemental fixation. Approved supplemental fixation includes the Olympic Posterior Spinal Fixation System. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. The SIRION Lateral Lumbar Interbody System Plate, in 2-hole and 4-hole configurations, is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of: fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery. The SIRION Lateral Lumbar Interbody System Plate, 1-hole buttress configuration is intended for use in conjunction with traditional supplemental fixation to maintain the relative position of interbody spacers during spinal fusion. The 1-hole plate is not intended for use in load-bearing applications. Hyperlordotic interbody devices (>20° lordosis) must be used in conjunction with the SIRION plate for fixation.

Source page: https://510kreport.com/device/K202495
Methodology: https://510kreport.com/methodology