Cleared Traditional

K181328 - T2 STRATOSPHERE™ Expandable Corpectomy System

K181328 is an FDA 510(k) clearance for T2 STRATOSPHERE Expandable Corpectomy S..., manufactured by Medtronic Sofamor Danek USA, Inc.. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K181328

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.

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 251
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
Blustone Synergy Silica System
K172330 · Blustone Synergy · Dec 2017