Class Class II
EL CAPITAN Anterior Lumbar Interbody Fusion (K222554)
Description
EL CAPITAN Anterior Lumbar Interbody Fusion by Astura Medical, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222554
Clearance Date2023-01-19
Clearance TypeTraditional
Product CodeOVD
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222554
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. EL CAPITAN Anterior Lumbar Interbody Fusion (K222554) cites 4 predicate devices and is itself cited by 3 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K192492 | EL CAPITAN Anterior Lumber Interbody System | Astura Medical, LLC | 2020 |
| K192006 | SIRION Lateral Lumbar Interbody System | Astura Medical, LLC | 2020 |
| K182877 | HALF DOME Posterior Lumbar Interbody System | Astura Medical, LLC | 2019 |
| K163481 | HALF DOME Posterior Lumbar Interbody System | Astura Medical | 2017 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K251644 | ProAM ALIF System | Pro Surgical, Inc. | 2025 |
| K240126 | ProAM ALIF System | Pro Surgical, Inc. | 2024 |
| K232292 | Peridot-EX Expandable Intervertebral Body Fusion System | Gbs Commonwealth Co., Ltd. | 2023 |
Trace the full predicate network for K222554
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.