Cleared Traditional

K063637 - RELIANCE VBS SYSTEM

K063637 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 Traditional 510(k) pathway after a 294-day FDA review.

K063637 · Reliance Medical Systems, LLC · Orthopedic device
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Sep 2007
Decision
294d
Days
Class 2
Risk

K063637 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 September 27, 2007 after a review of 294 days - an extended review 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: 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 Reliance Medical Systems, LLC devices

Submission Details

510(k) Number K063637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2006
Decision Date September 27, 2007
Days to Decision 294 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
172d slower than avg
Panel avg: 122d · This submission: 294d
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 159
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K063637.
BENGAL STACKABLE CAGE SYSTEM
K073649 · Depuy Spine, Inc. · Jan 2008
ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01
K080024 · K2m, Inc. · Jan 2008
NIKO CORPECTOMY SPACER
K072465 · Globus Medical, Inc. · Oct 2007
T2 XVBR SPINAL SYSTEM
K071033 · Medtronic Sofamor Danek · Aug 2007
VERTE-STACK SPINAL SYSTEM
K070173 · Medtronic Sofamor Danek, Inc. · Mar 2007
T2 SCEPTOR SPINAL SYSTEM
K063491 · Medtronic Sofamor Danek · Mar 2007