Cleared Traditional

K142150 - AIS MODULIFT VBR SYSTEM

K142150 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 85-day FDA review.

K142150 · Aesculap Implant System, Inc. · Orthopedic device
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Oct 2014
Decision
85d
Days
Class 2
Risk

K142150 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 October 29, 2014 after a review of 85 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 Aesculap Implant System, Inc. devices

Submission Details

510(k) Number K142150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2014
Decision Date October 29, 2014
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
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 K142150.
NuVasive X-CORE(R) Expandable VBR System
K142205 · Nuvasive, Inc. · Feb 2015
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