Cleared Special

K183049 - Reliance Lumbar IBF System

K183049 is the FDA 510(k) clearance for Reliance Lumbar IBF System by Reliance Medical Systems, LLC. It is a Class 2 Orthopedic device (product code MAX) cleared through the Special 510(k) pathway after a 105-day FDA review.

K183049 · Reliance Medical Systems, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2019
Decision
105d
Days
Class 2
Risk

K183049 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 February 15, 2019 after a review of 105 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. 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. Standard predicate reliance. 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 K183049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2018
Decision Date February 15, 2019
Days to Decision 105 days
Submission Type Special
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
17d faster than avg
Panel avg: 122d · This submission: 105d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 603
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K183049.
Idys™ TLIF TiVac
K183259 · Clariance, Sas · Mar 2019
IdentiTi Porous Ti Interbody System
K183705 · Alphatec Spine, Inc. · Mar 2019
Altus Spine Interbody Fusion System
K182406 · Altus Partners, LLC · Feb 2019
Omnia Medical Rotary PLIF System
K183659 · Omnia Medical, LLC · Feb 2019
EIT Cellular Titanium Lumbar Cage - T/PLIF
K183447 · Eit Emerging Implant Technologies GmbH · Feb 2019
Neo Cage System TM
K181048 · Neo Medical SA · Jan 2019