Cleared Traditional

K091883 - T2 SPINAL SYSTEM

K091883 is the FDA 510(k) clearance for T2 SPINAL SYSTEM 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 89-day FDA review.

K091883 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device
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Sep 2009
Decision
89d
Days
Class 2
Risk

K091883 is an FDA 510(k) clearance for the T2 SPINAL 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 21, 2009 after a review of 89 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 USA, Inc. devices

Submission Details

510(k) Number K091883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2009
Decision Date September 21, 2009
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
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 K091883.
STAXX XD SYSTEM
K101288 · Spine Wave, Inc. · Sep 2010
C-THRU SPINAL SYSTEM
K092336 · Ebi, L.P. · Oct 2009
VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX, 488814XX, 488816XX, 488818XX
K091946 · Stryker Spine · Sep 2009
STAXX XD SYSTEM
K090315 · Spine Wave, Inc. · Sep 2009
NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM
K090176 · Nuvasive, Inc. · Apr 2009
T2 XVBR SPINAL SYSTEM
K082112 · Medtronic Sofamor Danek · Aug 2008