Cleared Traditional

K181328 - T2 STRATOSPHERE Expandable Corpectomy S...

K181328 is the FDA 510(k) clearance for T2 STRATOSPHERE Expandable Corpectomy S... by Medtronic Sofamor Danek USA, Inc.. It is a Class 2 Orthopedic device (product code MQP) cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K181328 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device
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Sep 2018
Decision
124d
Days
Class 2
Risk

K181328 is an FDA 510(k) clearance for the T2 STRATOSPHERE™ Expandable Corpectomy System. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on September 19, 2018 after a review of 124 days - within the typical 510(k) review window.

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 Medtronic Sofamor Danek USA, Inc. devices

Submission Details

510(k) Number K181328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2018
Decision Date September 19, 2018
Days to Decision 124 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
2d slower than avg
Panel avg: 122d · This submission: 124d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 158
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K181328.
SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System
K180665 · K2m, LLC · Nov 2018
Solidity Vertebral Body Replacement
K181921 · Ulrich Medical USA · Nov 2018
FORTIFY Corpectomy Spacers
K173982 · Globus Medical, Inc. · Sep 2018
X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE® System, CONCORDE® Inline Lumbar Interbody System, CONCORDE® Curve Lumbar Interbody System, CONCORDE® Bullet Lumbar Interbody System, COUGAR® System, COUGAR® LS Lateral Cage System, DEVEX® System, LEOPARD® System, DePuy PULSE Cervical Cage System, DePuy PULSE Lumbar Cage System, LUMBAR I/F CAGE® System
K173787 · Medos International SARL · Jun 2018
Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy Cage
K173800 · Camber Spine Technologies · Feb 2018
T2 STRATOSPHERE™ Expandable Corpectomy System
K173125 · Medtronic Sofamor Danek · Dec 2017