Cleared Traditional

K173125 - T2 STRATOSPHERE™ Expandable Corpectomy System

K173125 is an FDA 510(k) clearance for T2 STRATOSPHERE Expandable Corpectomy S..., manufactured by Medtronic Sofamor Danek. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K173125 · Medtronic Sofamor Danek · Orthopedic device
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Dec 2017
Decision
82d
Days
Class 2
Risk

K173125 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 (Memphis, US). The FDA issued a Cleared decision on December 20, 2017 after a review of 82 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtronic Sofamor Danek devices

FDA 510(k) Submission Details - K173125

510(k) Number K173125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2017
Decision Date December 20, 2017
Days to Decision 82 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
40d faster than avg
Panel avg: 122d · This submission: 82d
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 237
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K173125.
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
FORTIFY Corpectomy Spacers
K162315 · Globus Medical, Inc. · Nov 2017
Omnia Medical VBR
K172323 · Omnia Medical, LLC · Oct 2017
Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System
K171686 · Choicespine · Sep 2017