# K192492: EL CAPITAN Anterior Lumber Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Astura Medical, LLC
- Decided: Apr 21, 2020 after 223 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: 20 generations back to K841189 (1984). 287 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 298 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K141791: Biomet Fusion System, Biomet Spine (2014) Summary page 4.
- K163543: Biomet Fusion System, Zimmer Biomet Spine, Inc. (2017) Summary page 4.
- K013665: Pyramid Anterior Plate Fixation System, Medtronic Sofamor Danek, Inc. (2002) Summary page 4.
- K170592: NuVasive BASE Interfixated Titanium System, Nu Vasive, Incorporated (2017) Summary page 4.
- K143163: AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System, Stryker Corporation (2015) Summary page 4.
- K180814: CoreLink® M3™ Stand-Alone Anterior Lumbar System, Corelink, LLC (2018) Summary page 4.

## Most influential descendants
- 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
- K233509: Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System (2024), 1 descendant of its own

## Indications for use
The EL CAPITAN Anterior 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 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, 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) 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/K192492
Methodology: https://510kreport.com/methodology