Cleared Special

K181792 - Duo™ Lumbar Interbody Fusion Device

K181792 is an FDA 510(k) clearance for Duo Lumbar Interbody Fusion Device, manufactured by Spineology, Inc.. The device is a Class 2 Orthopedic device with product code MAX cleared through the Special 510(k) pathway after a 40-day FDA review.

K181792 · Spineology, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2018
Decision
40d
Days
Class 2
Risk

K181792 is an FDA 510(k) clearance for the Duo™ Lumbar Interbody Fusion Device. 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 Spineology, Inc. (Saint Paul, US). The FDA issued a Cleared decision on August 14, 2018 after a review of 40 days - a notably fast clearance cycle.

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. 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.

FDA 510(k) Submission Details - K181792

510(k) Number K181792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2018
Decision Date August 14, 2018
Days to Decision 40 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
82d faster than avg
Panel avg: 122d · This submission: 40d
Pathway characteristics
Modification to existing cleared device.

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 898
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K181792.
Tranquil Interbody System
K181483 · Nexus Spine, LLC · Aug 2018
CancelleX Porous Titanium Lumbar Interbody Device
K180373 · Xenco Medical, LLC · Aug 2018
Aries® Lumbar Interbodies
K181347 · Osseus Fusion Systems, LLC · Aug 2018
TirboLOX-L Lumbar IBFD
K180990 · Captiva Spine, Inc. · Aug 2018
K2M Expandable Interbody System
K180777 · K2m, Inc. · Aug 2018
Ti 3Z Interbody System
K180076 · Zavation Medical Products, LLC · Jul 2018
K181792 · Duo™ Lumbar Interbody Fusion Device
Download PDF FDA Summary Spineology, Inc.