Cleared Traditional

K083186 - AESCULAP HYDROLIFT VBR SYSTEM

K083186 is the FDA 510(k) clearance for AESCULAP HYDROLIFT 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 491-day FDA review.

K083186 · Aesculap Implant System, Inc. · Orthopedic device
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Mar 2010
Decision
491d
Days
Class 2
Risk

K083186 is an FDA 510(k) clearance for the AESCULAP HYDROLIFT 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 March 4, 2010 after a review of 491 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Aesculap Implant System, Inc. devices

Submission Details

510(k) Number K083186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2008
Decision Date March 04, 2010
Days to Decision 491 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
369d slower than avg
Panel avg: 122d · This submission: 491d
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 K083186.
STAXX(R) XD SYSTEM
K102682 · Spine Wave, Inc. · Nov 2010
T2 XVBR 1.5 SPINAL SYSTEM
K100976 · Medtronic Sofamor Danek USA, Inc. · Oct 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
T2 SPINAL SYSTEM
K091883 · Medtronic Sofamor Danek USA, Inc. · Sep 2009