Cleared Special

K122168 - VISUALIF CHALLENGING ACCESS PLATE

K122168 is an FDA 510(k) clearance for VISUALIF CHALLENGING ACCESS PLATE, manufactured by Spine Smith Partners L.P.. The device is a Class 2 Orthopedic device with product code OVD cleared through the Special 510(k) pathway after a 80-day FDA review.

K122168 · Spine Smith Partners L.P. · Orthopedic device
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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

FDA 510(k) Submission Details - K122168

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.

OVD Device Classification - Class 2, Special Controls

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 159
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K122168.
LANX FUSION SYSTEM- SA
K123767 · Lanx, Inc. · Mar 2013
SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
K123993 · Alphatec Spine, Inc. · Mar 2013
ANCHOR-L LUMBAR CAGE
K120869 · Stryker Spine · Oct 2012
SOVEREIGN SPINAL SYSTEM
K121982 · Medtronic Sofamor Danek · Jul 2012
VU APOD INTERVERTEBRAL BODY FUSION DEVICE
K121211 · Theken Spine, LLC · Jun 2012
INDEPENDENCE SPACER
K120101 · Globus Medical, Inc. · Mar 2012