Cleared Traditional

K190426 - ALTA Anterior Cervical Corpectomy System

K190426 is an FDA 510(k) clearance for ALTA Anterior Cervical Corpectomy System, manufactured by Astura Medical, LLC. The device is a Class 2 Orthopedic device with product code PLR cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K190426 · Astura Medical, LLC · Orthopedic device
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Oct 2019
Decision
244d
Days
Class 2
Risk

K190426 is an FDA 510(k) clearance for the ALTA Anterior Cervical Corpectomy System. Classified as Spinal Vertebral Body Replacement Device - Cervical (product code PLR), Class II - Special Controls.

Submitted by Astura Medical, LLC (Carlsbad, US). The FDA issued a Cleared decision on October 24, 2019 after a review of 244 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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

FDA 510(k) Submission Details - K190426

510(k) Number K190426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2019
Decision Date October 24, 2019
Days to Decision 244 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
122d slower than avg
Panel avg: 122d · This submission: 244d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PLR Device Classification - Class 2, Special Controls

Product Code PLR Spinal Vertebral Body Replacement Device - Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
Definition Vertebral Body Replacement In The Cervical Spine.
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 - PLR Spinal Vertebral Body Replacement Device - Cervical

All 15
Devices cleared under the same product code (PLR) and FDA review panel - the closest regulatory comparables to K190426.
Galileo Vertebral Body Replacement Device
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NEXXT MATRIXX System
K193412 · Nexxt Spine, LLC · Feb 2020
Bengal Stackable Cage System
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Omnia Medical VBR
K191778 · Omnia Medical, LLC · Aug 2019
Normandy VBR System
K191423 · Zavation Medical Products, LLC · Aug 2019
VLIFT-s Vertebral Body Replacement System
K183071 · Stryker Spine · Jan 2019