Cleared Traditional

K113540 - RELIANCE LUMBAR IBF SYSTEM

K113540 is an FDA 510(k) clearance for RELIANCE LUMBAR IBF SYSTEM, manufactured by Reliance Medical Systems, LLC. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K113540 · Reliance Medical Systems, LLC · Orthopedic device
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Mar 2012
Decision
103d
Days
Class 2
Risk

K113540 is an FDA 510(k) clearance for the RELIANCE LUMBAR IBF SYSTEM. Classified as Intervertebral Fusion Device With Bone Graft, Lumbar within the MAX classification (a category for intervertebral fusion devices and spinal implants), Class II - Special Controls.

Submitted by Reliance Medical Systems, LLC (Bountiful, US). The FDA issued a Cleared decision on March 12, 2012 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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

FDA 510(k) Submission Details - K113540

510(k) Number K113540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2011
Decision Date March 12, 2012
Days to Decision 103 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
19d faster than avg
Panel avg: 122d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAX Device Classification - Class 2, Special Controls

Product Code MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
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 - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 849
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K113540.
CAPSTONE CONTROL SPINAL SYSTEM
K120368 · Medtronic Sofamor Danek USA, Inc. · Apr 2012
ZAVATION IBF SYSTEM
K120576 · Zavation, LLC · Mar 2012
ASFORA BULLET CAGE
K112648 · Medical Designs, LLC · Mar 2012
MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINI
K111792 · Signus Medizintechnik GmbH · Mar 2012
PLIF CAGE
K113478 · Eisertech, LLC · Mar 2012
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DRIVE
K120293 · Spineology, Inc. · Feb 2012