Cleared Traditional

SEC VBR (K091743) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K091743 · Innvotec Surgical, Inc. · Orthopedic device
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Nov 2009
Decision
139d
Days
Class 2
Risk

K091743 is an FDA 510(k) clearance for the SEC VBR. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Innvotec Surgical, Inc. (Washington, US). The FDA issued a Cleared decision on November 2, 2009 after a review of 139 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 Innvotec Surgical, Inc. devices

Submission Details

510(k) Number K091743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2009
Decision Date November 02, 2009
Days to Decision 139 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 122d · This submission: 139d
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 68
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K091743.
FORTIFY INTEGRATED CORPECTOMY SPACERS, (FORTIFY I AND FORTIFY I-R)
K121107 · Globus Medical, Inc. · Jul 2012
FORTIFY(TM) AND FORTIFY(TM)-R CORPECTOMY SPACERS
K112756 · Globus Medical, Inc. · Oct 2011
T2 XVBR 1.5 SPINAL SYSTEM
K100976 · Medtronic Sofamor Danek USA, Inc. · Oct 2010
T2 SPINAL SYSTEM
K091883 · Medtronic Sofamor Danek USA, Inc. · Sep 2009
T2 XVBR SPINAL SYSTEM
K082112 · Medtronic Sofamor Danek · Aug 2008
NIKO CORPECTOMY SPACER
K072465 · Globus Medical, Inc. · Oct 2007