Cleared Traditional

EL CAPITAN Anterior Lumber Interbody System (K192492) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K192492 · Astura Medical, LLC · Orthopedic device
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Apr 2020
Decision
223d
Days
Class 2
Risk

K192492 is an FDA 510(k) clearance for the EL CAPITAN Anterior Lumber Interbody System. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Astura Medical, LLC (Carlsbad, US). The FDA issued a Cleared decision on April 21, 2020 after a review of 223 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Astura Medical, LLC devices

Submission Details

510(k) Number K192492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2019
Decision Date April 21, 2020
Days to Decision 223 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 122d · This submission: 223d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

All 115
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K192492.
Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device
K200002 · 4Web, Inc. · May 2020
Axis Spine Technologies ALIF
K200352 · Axis Spine Technologies, Ltd. · May 2020
Hive™ Stand-alone Anterior Lumbar Interbody System
K200541 · Hd Lifesciences, LLC · Apr 2020
ProLift Lateral Fixated
K200338 · Life Spine, Inc. · Apr 2020
NuVasive 3DP Interfixated ALIF System
K193593 · Nu Vasive, Incorporated · Mar 2020
KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System
K193320 · Kyocera Medical Technologies, Inc. · Feb 2020