Cleared Special

VISUALIF CHALLENGING ACCESS PLATE (K122168) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K122168 · Spine Smith Partners L.P. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
80d
Days
Class 2
Risk

K122168 is an FDA 510(k) clearance for the VISUALIF CHALLENGING ACCESS PLATE. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Spine Smith Partners L.P. (Austin, US). The FDA issued a Cleared decision on October 11, 2012 after a review of 80 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.

View all Spine Smith Partners L.P. devices

Submission Details

510(k) Number K122168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2012
Decision Date October 11, 2012
Days to Decision 80 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
42d faster than avg
Panel avg: 122d · This submission: 80d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.
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 - OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

All 110
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K122168.
TransContinental® M Spacers and InterContinental® Plate-Spacers
K161223 · Globus Medical, Inc. · Jul 2016
MAGNIFY and MAGNIFY-S Spacers
K142498 · Globus Medical, Inc. · Feb 2015
MONUMENT SPACERS
K132559 · Globus Medical, Inc. · Dec 2013
INDEPENDENCE SPACER
K120101 · Globus Medical, Inc. · Mar 2012
INTERCONTINENTAL PLATE-SPACER
K103382 · Globus Medical, Inc. · May 2011
INDEPENDENCE SPACER
K082252 · Globus Medical, Inc. · Nov 2008