# K222554: EL CAPITAN Anterior Lumbar Interbody Fusion

- Pathway: 510(k) (Traditional)
- Applicant: Astura Medical
- Decided: Jan 19, 2023 after 149 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: 25 generations back to K841189 (1984). 354 ancestors in all.
5 later devices descend from it; 4 cite it directly.
1 of 360 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192492: EL CAPITAN Anterior Lumber Interbody System, Astura Medical, LLC (2020) Summary page 4.
- K163481: HALF DOME Posterior Lumbar Interbody System, Astura Medical (2017) Summary page 4.
- K182877: HALF DOME Posterior Lumbar Interbody System, Astura Medical, LLC (2019) Summary page 4.
- K192006: SIRION Lateral Lumbar Interbody System, Astura Medical, LLC (2020) Summary page 4.

## Most influential descendants
- K240126: ProAM ALIF System (2024), 2 descendants of its own
- K261353: Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System (2026), 0 descendants of its own
- K251644: ProAM ALIF System (2025), 0 descendants of its own
- K242517: ProAM ACDF System (2024), 0 descendants of its own
- K232292: Peridot-EX Expandable Intervertebral Body Fusion System (2023), 0 descendants of its own

## Indications for use
The EL CAPITAN Anterior Lumbar Interbody Fusion 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). EL CAPITAN system 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 EL CAPITAN spacer and plate assembly are an integrated interbody fusion device intended for stand-alone use when used with all titanium alloy screws. When used with anchors only the zero plate may be used and the assembly is intended for use with additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine. Hyperlordotic interbody devices (>20° lordosis), Oblique interbody devices and EL CAPITAN X must be used with supplemental fixation (e.g. posterior fixation) that has been cleared by the FDA for use in the lumbar spine. The EL CAPITAN X spacer may only be used with titanium alloy screws.

Source page: https://510kreport.com/device/K222554
Methodology: https://510kreport.com/methodology