Cleared Special

K081383 - RELIANCE VBS SYSTEM

K081383 is the FDA 510(k) clearance for RELIANCE VBS SYSTEM by Reliance Medical Systems, LLC. It is a Class 2 Orthopedic device (product code MQP) cleared through the Special 510(k) pathway after a 47-day FDA review.

K081383 · Reliance Medical Systems, LLC · Orthopedic device
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Jul 2008
Decision
47d
Days
Class 2
Risk

K081383 is an FDA 510(k) clearance for the RELIANCE VBS SYSTEM. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Reliance Medical Systems, LLC (Sandy, US). The FDA issued a Cleared decision on July 2, 2008 after a review of 47 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Reliance Medical Systems, LLC devices

Submission Details

510(k) Number K081383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2008
Decision Date July 02, 2008
Days to Decision 47 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 122d · This submission: 47d
Pathway characteristics
Modification to existing cleared device.

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 159
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K081383.
STAXX XD SYSTEM
K090315 · Spine Wave, Inc. · Sep 2009
NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM
K090176 · Nuvasive, Inc. · Apr 2009
T2 XVBR SPINAL SYSTEM
K082112 · Medtronic Sofamor Danek · Aug 2008
NOVEL SPINAL SPACER SYSTEM
K080699 · Alphatec Spine, Inc. · May 2008
X-MESH EXPANDABLE CAGE SYSTEM
K080568 · Depuy Spine, Inc. · May 2008
BENGAL STACKABLE CAGE SYSTEM
K073649 · Depuy Spine, Inc. · Jan 2008