Cleared Traditional

K100976 - T2 XVBR 1.5 SPINAL SYSTEM

K100976 is the FDA 510(k) clearance for T2 XVBR 1.5 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 196-day FDA review.

K100976 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device
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Oct 2010
Decision
196d
Days
Class 2
Risk

K100976 is an FDA 510(k) clearance for the T2 XVBR 1.5 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 October 21, 2010 after a review of 196 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 Medtronic Sofamor Danek USA, Inc. devices

Submission Details

510(k) Number K100976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2010
Decision Date October 21, 2010
Days to Decision 196 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
74d slower than avg
Panel avg: 122d · This submission: 196d
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 K100976.
STAXX XDL SYSTEM
K102315 · Spine Wave, Inc. · Aug 2011
STAXXSD SYSTEM
K111469 · Spine Wave, Inc. · Jul 2011
STAXX(R) XD SYSTEM
K102682 · Spine Wave, Inc. · Nov 2010
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