Cleared Special

K140715 - ZIP MIS INTERSPINOUS FUSION SYSTEM

K140715 is an FDA 510(k) clearance for ZIP MIS INTERSPINOUS FUSION SYSTEM, manufactured by Aurora Spine, Inc.. The device is a Class 2 Orthopedic device with product code PEK cleared through the Special 510(k) pathway after a 27-day FDA review.

K140715 · Aurora Spine, Inc. · Orthopedic device
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Apr 2014
Decision
27d
Days
Class 2
Risk

K140715 is an FDA 510(k) clearance for the ZIP MIS INTERSPINOUS FUSION SYSTEM. Classified as Spinous Process Plate (product code PEK), Class II - Special Controls.

Submitted by Aurora Spine, Inc. (Washington, US). The FDA issued a Cleared decision on April 17, 2014 after a review of 27 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 Aurora Spine, Inc. devices

FDA 510(k) Submission Details - K140715

510(k) Number K140715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2014
Decision Date April 17, 2014
Days to Decision 27 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 122d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 K140715.
VIA SPINOUS PROCESS FIXATION SYSTEM
K142213 · Spineology, Inc. · Sep 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
SP-FIX SPINOUS PROCESS FIXATION PLATE
K132191 · Globus Medical, Inc. · Nov 2013
AFFIX II SPINOUS PROCESS PLATE SYSTEM
K132411 · Nu Vasive, Incorporated · Nov 2013