Cleared Special

K142213 - VIA SPINOUS PROCESS FIXATION SYSTEM

K142213 is the FDA 510(k) clearance for VIA SPINOUS PROCESS FIXATION SYSTEM by Spineology, Inc.. It is a Class 2 Orthopedic device (product code PEK) cleared through the Special 510(k) pathway after a 29-day FDA review.

K142213 · Spineology, Inc. · Orthopedic device
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Sep 2014
Decision
29d
Days
Class 2
Risk

K142213 is an FDA 510(k) clearance for the VIA SPINOUS PROCESS FIXATION SYSTEM. Classified as Spinous Process Plate (product code PEK), Class II - Special Controls.

Submitted by Spineology, Inc. (St. Paul, US). The FDA issued a Cleared decision on September 10, 2014 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Spineology, Inc. devices

Submission Details

510(k) Number K142213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2014
Decision Date September 10, 2014
Days to Decision 29 days
Submission Type Special
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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 K142213.
Spinal Elements' Spinous Process Plate System
K160465 · Spinal Elements, Inc. · Jul 2016
Affix IIS Spinous Process Plate System
K143388 · Nu Vasive, Incorporated · Mar 2015
AILERON INTERSPINOUS FIXATION SYSTEM
K140236 · Life Spine, Inc. · Oct 2014
ROMEO 2 PAD POSTERIOR AXIAL DEVICE
K141508 · Spineart · Aug 2014
PFX SPINOUS PROCESS FIXATION SYSTEM
K132765 · Innovasis, Inc. · Jul 2014
AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEM
K133052 · Nuvasive, Inc. · Dec 2013