Cleared Traditional

K233359 - DOMINION Expandable Corpectomy System

K233359 is an FDA 510(k) clearance for DOMINION Expandable Corpectomy System, manufactured by Astura Medical. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K233359 · Astura Medical · Orthopedic device
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Mar 2024
Decision
161d
Days
Class 2
Risk

K233359 is an FDA 510(k) clearance for the DOMINION Expandable Corpectomy System. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Astura Medical (Irving, US). The FDA issued a Cleared decision on March 8, 2024 after a review of 161 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 devices

FDA 510(k) Submission Details - K233359

510(k) Number K233359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2023
Decision Date March 08, 2024
Days to Decision 161 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
39d slower than avg
Panel avg: 122d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQP Device Classification - Class 2, Special Controls

Product Code MQP Spinal Vertebral Body Replacement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - MQP Spinal Vertebral Body Replacement Device

All 236
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K233359.
VyBrate™ VBR System
K253158 · Vy Spine, LLC · Jan 2026
Vertiwedge® Intraosseous System
K241468 · Foundation Surgical Group, Inc. · Nov 2024
KONG®-TL VBR System and KONG® C VBR System
K232790 · Icotec AG · Apr 2024
VerteLoc Spinal System
K231134 · Signature Orthopaedics Pty, Ltd. · Feb 2024
Ascend VBR System, Ascend NanoTec VBR System
K232173 · Alphatec Spine, Inc. · Oct 2023
ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)
K211892 · Arftx Medical, LLC · Oct 2022