Cleared Traditional

K121551 - RESOLUTE FACET SCREW SYSTEM

K121551 · Neurostructures, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
151d
Days
-
Risk

K121551 is an FDA 510(k) clearance for the RESOLUTE FACET SCREW SYSTEM. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Neurostructures, LLC (Colorado Springs, US). The FDA issued a Cleared decision on October 23, 2012 after a review of 151 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Neurostructures, LLC devices

FDA 510(k) Submission Details - K121551

510(k) Number K121551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2012
Decision Date October 23, 2012
Days to Decision 151 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 122d · This submission: 151d
Pathway characteristics
Predicate-based equivalence.

MRW Device Classification - Class 0,

Product Code MRW System, Facet Screw Spinal Device
Device Class -

Regulatory Peers - MRW System, Facet Screw Spinal Device

All 59
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K121551.
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K123218 · Alphatec Spine, Inc. · Nov 2012
Typhoon(TM) Facet Screw Fixation System
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K110170 · Alphatec Spine, Inc. · Nov 2011
GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5
K112097 · Exactech, Inc. · Nov 2011