Cleared Traditional

K132765 - PFX SPINOUS PROCESS FIXATION SYSTEM

K132765 is an FDA 510(k) clearance for PFX SPINOUS PROCESS FIXATION SYSTEM, manufactured by Innovasis, Inc.. The device is a Class 2 Orthopedic device with product code PEK cleared through the Traditional 510(k) pathway after a 313-day FDA review.

K132765 · Innovasis, Inc. · Orthopedic device
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Jul 2014
Decision
313d
Days
Class 2
Risk

K132765 is an FDA 510(k) clearance for the PFX SPINOUS PROCESS FIXATION SYSTEM. Classified as Spinous Process Plate (product code PEK), Class II - Special Controls.

Submitted by Innovasis, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on July 14, 2014 after a review of 313 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 Innovasis, Inc. devices

FDA 510(k) Submission Details - K132765

510(k) Number K132765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2013
Decision Date July 14, 2014
Days to Decision 313 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
191d slower than avg
Panel avg: 122d · This submission: 313d
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 47
Devices cleared under the same product code (PEK) and FDA review panel - the closest regulatory comparables to K132765.
AILERON INTERSPINOUS FIXATION SYSTEM
K140236 · Life Spine, Inc. · Oct 2014
VIA SPINOUS PROCESS FIXATION SYSTEM
K142213 · Spineology, Inc. · Sep 2014
ROMEO 2 PAD POSTERIOR AXIAL DEVICE
K141508 · Spineart · Aug 2014
ZIP MIS INTERSPINOUS FUSION SYSTEM
K140715 · Aurora Spine, Inc. · Apr 2014
INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM
K133363 · Ldr Spine USA, Inc. · Mar 2014
AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEM
K133052 · Nuvasive, Inc. · Dec 2013