Cleared Traditional

K133802 - AIS MODULIFT VBR SYSTEM

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

K133802 · Aesculap Implant System, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K133802

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
Combination Product No
PCCP Authorized No
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.

MQP Device Classification - Class 2, Special Controls

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 237
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K133802.
CAPRI
K142016 · K2m, Inc. · Nov 2014
AIS MODULIFT VBR SYSTEM
K142150 · Aesculap Implant System, Inc. · Oct 2014
LATERAL VBR SYSTEM
K140563 · Nu Vasive, Incorporated · Aug 2014
TASMIN R
K123758 · Signus Medizintechnik GmbH · Jan 2014
PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE
K131724 · Pioneer Surgical Technology, Inc. · Dec 2013
STAXX(R) SYSTEM
K133207 · Spine Wave, Inc. · Dec 2013