Cleared Special

K190322 - SCARLET AC-T Secured Anterior Cervical ...

K190322 is the FDA 510(k) clearance for SCARLET AC-T Secured Anterior Cervical ... by Spineart. It is a Class 2 Orthopedic device (product code ODP) cleared through the Special 510(k) pathway after a 19-day FDA review.

K190322 · Spineart · Orthopedic device
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Mar 2019
Decision
19d
Days
Class 2
Risk

K190322 is an FDA 510(k) clearance for the SCARLET® AC-T Secured Anterior Cervical Cage. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Spineart (Plan Les Ouates, CH). The FDA issued a Cleared decision on March 4, 2019 after a review of 19 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.

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Submission Details

510(k) Number K190322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2019
Decision Date March 04, 2019
Days to Decision 19 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
103d faster than avg
Panel avg: 122d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code ODP Intervertebral Fusion Device With Bone Graft, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical 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 - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 219
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K190322.
RIGEL PEEK Anterior Cervical Interbody Fusion System
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K190067 · U&I Corporation · Feb 2019