# K223335: SIRION Lateral Lumbar Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Astura Medical
- Decided: May 9, 2023 after 189 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). 483 ancestors in all.
No later device cites it as a predicate yet.
1 of 484 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.
- K182877: HALF DOME Posterior Lumbar Interbody System, Astura Medical, LLC (2019) Summary page 4.
- K152512: Half Dome Posterior Lumbar Interbody System, Astura Medical (2016) Summary page 4.
- K071724: Lucent, Spinal Elements, Inc. (2007) Summary page 4.
- K081968: Modification to Lucent, Spinal Elements, Inc. (2008) Summary page 4.
- K113447: Rise Spacer, Globus Medical, Inc. (2012) Summary page 4.
- K210061: ProLift Lateral HELO Fixated, Life Spine, Inc. (2021) Summary page 4.
- K211740: DualX, Amplify Surgical, Inc. (2021) Summary page 4.

## 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. SIRION X must be used with supplemental fixation (e.g. posterior fixation) that has been cleared by the FDA for use in the lumbar spine.

Source page: https://510kreport.com/device/K223335
Methodology: https://510kreport.com/methodology