Cleared Traditional

K083186 - AESCULAP HYDROLIFT VBR SYSTEM

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

K083186 · Aesculap Implant System, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K083186

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
Combination Product No
PCCP Authorized No
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.

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 Consultant

Aesculap AG
Kathy Racosky

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 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
ADDPLUS
K090841 · Ulrich GmbH & Co. KG · Oct 2009
VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX, 488814XX, 488816XX, 488818XX
K091946 · Stryker Spine · Sep 2009