Cleared Traditional

K133802 - AIS MODULIFT VBR SYSTEM

K133802 is the FDA 510(k) clearance for AIS MODULIFT VBR SYSTEM by Aesculap Implant System, Inc.. It is a Class 2 Orthopedic device (product code MQP) cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K133802 · Aesculap Implant System, Inc. · Orthopedic device
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Apr 2014
Decision
125d
Days
Class 2
Risk

K133802 is an FDA 510(k) clearance for the AIS MODULIFT VBR SYSTEM. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Aesculap Implant System, Inc. (Center Valley, US). The FDA issued a Cleared decision on April 17, 2014 after a review of 125 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 Aesculap Implant System, Inc. devices

Submission Details

510(k) Number K133802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2013
Decision Date April 17, 2014
Days to Decision 125 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
3d slower than avg
Panel avg: 122d · This submission: 125d
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 153
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K133802.
StaXx(R) XD System
K142996 · Spine Wave, Inc. · Feb 2015
CAPRI
K142016 · K2m, Inc. · Nov 2014
LATERAL VBR SYSTEM
K140563 · Nu Vasive, Incorporated · Aug 2014
STAXX(R) SYSTEM
K133207 · Spine Wave, Inc. · Dec 2013
T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE
K131888 · Medtronic Sofamor Danek, Inc. · Sep 2013
STAXX XD SYSTEM
K121889 · Spine Wave, Inc. · Aug 2012