Cleared Traditional

K110170 - RAPTOR FACET FIXATION SYSTEM

K110170 · Alphatec Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
312d
Days
-
Risk

K110170 is an FDA 510(k) clearance for the RAPTOR FACET FIXATION SYSTEM. Classified as System, Facet Screw Spinal Device (product code MRW).

Submitted by Alphatec Spine, Inc. (Carlsnad, US). The FDA issued a Cleared decision on November 28, 2011 after a review of 312 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Alphatec Spine, Inc. devices

FDA 510(k) Submission Details - K110170

510(k) Number K110170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2011
Decision Date November 28, 2011
Days to Decision 312 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
190d slower than avg
Panel avg: 122d · This submission: 312d
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 74
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K110170.
VENUS FACET SCREW SYSTEM
K120340 · Apollo Spine, Inc. · Oct 2012
Typhoon(TM) Facet Screw Fixation System
K121850 · Choicespine, LP · Sep 2012
SPARTAN S3 FACET SYSTEM
K113011 · Amendia, Inc. · Dec 2011
GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5
K112097 · Exactech, Inc. · Nov 2011
VIPER F2 FACET FIXATION SYSTEM
K101762 · Depuy Spine, Inc. · Nov 2010
PRIMALOK FACET FIXATION SYSTEM
K102438 · Osteomed LP · Sep 2010