Cleared Traditional

K180817 - AERIAL Interspinous Fixation

K180817 is the FDA 510(k) clearance for AERIAL Interspinous Fixation by Globus Medical, Inc.. It is a Class 2 Orthopedic device (product code PEK) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K180817 · Globus Medical, Inc. · Orthopedic device
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May 2018
Decision
53d
Days
Class 2
Risk

K180817 is an FDA 510(k) clearance for the AERIAL™ Interspinous Fixation. Classified as Spinous Process Plate (product code PEK), Class II - Special Controls.

Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on May 21, 2018 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Globus Medical, Inc. devices

Submission Details

510(k) Number K180817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2018
Decision Date May 21, 2018
Days to Decision 53 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
69d faster than avg
Panel avg: 122d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PEK Spinous Process Plate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
Definition A Posterior, Non-pedicle Supplemental Fixation Device Intended For Single Level Use In The Non-cervical Spine (t1-s1). It Is Intended For Single Level Plate Fixation/attachment To Spinous Process For The Purpose Of Achieving Supplemental Fusion In The Following Conditions: Degenerative Disc Disease (defined As Back Pain Of Discogenic Origin With Degeneration Of The Disc Confirmed By History And Radiographic Studies), Trauma (i.e., Fracture Or Dislocation), Spondylolisthesis, And/or Tumor. It Is Not Intended For Stand-alone Use.
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 - PEK Spinous Process Plate

All 28
Devices cleared under the same product code (PEK) and FDA review panel - the closest regulatory comparables to K180817.
Posterior Fusion Plate, HA Posterior Fusion Plate
K200066 · Spinal Simplicity, LLC · Dec 2020
CoFix System
K201704 · Paradigm Spine GmbH · Aug 2020
SP-LINK™ System
K182352 · Medical Designs, LLC · Nov 2018
SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System
K180156 · Globus Medical, Inc. · Mar 2018
SeaSpine Spinous Process System
K173334 · SeaSpine Orthopedics Corporation · Feb 2018
Spinal Elements' Spinous Process Plate System
K160465 · Spinal Elements, Inc. · Jul 2016