Cleared Traditional

RAPTOR FACET FIXATION SYSTEM (K110170) - FDA 510(k) Clearance

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

Submission Details

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
Regulatory Context
Review time vs. panel average
190d slower than avg
Panel avg: 122d · This submission: 312d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

Regulatory Peers - MRW System, Facet Screw Spinal Device

All 32
Devices cleared under the same product code (MRW) and FDA review panel - the closest regulatory comparables to K110170.
PMT Facet Screw
K183589 · Providence Medical Technology, Inc. · Oct 2019
FaSet Fixation System
K180729 · Huvexel Co. , Ltd. · Jun 2018
Facet Screw Fixation System
K173198 · U&I Corporation · Jan 2018
GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5
K112097 · Exactech, Inc. · Nov 2011
ZYFUSE FACET FIXATION SYSTEM
K090952 · Globus Medical, Inc. · Jul 2009
CORRIDOR FIXATION SYSTEM
K083442 · Globus Medical, Inc. · Feb 2009