Cleared Traditional

K120340 - VENUS FACET SCREW SYSTEM

K120340 · Apollo Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
259d
Days
-
Risk

K120340 is an FDA 510(k) clearance for the VENUS FACET SCREW SYSTEM. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Apollo Spine, Inc. (Stoughton, US). The FDA issued a Cleared decision on October 19, 2012 after a review of 259 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.

FDA 510(k) Submission Details - K120340

510(k) Number K120340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2012
Decision Date October 19, 2012
Days to Decision 259 days
Submission Type Traditional
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
137d slower than avg
Panel avg: 122d · This submission: 259d
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 78
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K120340.
FACET SCREW SYSTEM
K123497 · Facet-Link, Inc. · Feb 2013
ILLICO FS FACET FIXATION SYSTEM
K123218 · Alphatec Spine, Inc. · Nov 2012
RESOLUTE FACET SCREW SYSTEM
K121551 · Neurostructures, LLC · Oct 2012
Typhoon(TM) Facet Screw Fixation System
K121850 · Choicespine, LP · Sep 2012
SPARTAN S3 FACET SYSTEM
K113011 · Amendia, Inc. · Dec 2011
RAPTOR FACET FIXATION SYSTEM
K110170 · Alphatec Spine, Inc. · Nov 2011
K120340 · VENUS FACET SCREW SYSTEM
Download PDF FDA Summary Apollo Spine, Inc.