Cleared Traditional

K140046 - SPINOUS PROCESS FUSION (SPF) PLATE

K140046 is an FDA 510(k) clearance for SPINOUS PROCESS FUSION (SPF) PLATE, manufactured by Spinal Simplicity, LLC. The device is a Class 2 Orthopedic device with product code PEK cleared through the Traditional 510(k) pathway after a 366-day FDA review.

K140046 · Spinal Simplicity, LLC · Orthopedic device
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Jan 2015
Decision
366d
Days
Class 2
Risk

K140046 is an FDA 510(k) clearance for the SPINOUS PROCESS FUSION (SPF) PLATE. Classified as Spinous Process Plate (product code PEK), Class II - Special Controls.

Submitted by Spinal Simplicity, LLC (Philedelphia, US). The FDA issued a Cleared decision on January 9, 2015 after a review of 366 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Spinal Simplicity, LLC devices

FDA 510(k) Submission Details - K140046

510(k) Number K140046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2014
Decision Date January 09, 2015
Days to Decision 366 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
244d slower than avg
Panel avg: 122d · This submission: 366d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PEK Device Classification - Class 2, Special Controls

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 35
Devices cleared under the same product code (PEK) and FDA review panel - the closest regulatory comparables to K140046.
Precision Spine Interspinous Plate System
K151863 · Precision Spine, Inc. · Aug 2015
Reliance Interspinous Plate System
K142217 · Reliance Medical Systems, LLC · Apr 2015
Affix IIS Spinous Process Plate System
K143388 · Nu Vasive, Incorporated · Mar 2015
Interspinous Plate System
K142378 · Precision Spine, Inc. · Dec 2014
AILERON INTERSPINOUS FIXATION SYSTEM
K140236 · Life Spine, Inc. · Oct 2014
VIA SPINOUS PROCESS FIXATION SYSTEM
K142213 · Spineology, Inc. · Sep 2014