Cleared Traditional

K132191 - SP-FIX SPINOUS PROCESS FIXATION PLATE

K132191 is an FDA 510(k) clearance for SP-FIX SPINOUS PROCESS FIXATION PLATE, manufactured by Globus Medical, Inc.. The device is a Class 2 Orthopedic device with product code PEK cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K132191 · Globus Medical, Inc. · Orthopedic device
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Nov 2013
Decision
130d
Days
Class 2
Risk

K132191 is an FDA 510(k) clearance for the SP-FIX SPINOUS PROCESS FIXATION PLATE. 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 November 22, 2013 after a review of 130 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Globus Medical, Inc. devices

FDA 510(k) Submission Details - K132191

510(k) Number K132191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2013
Decision Date November 22, 2013
Days to Decision 130 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
8d slower than avg
Panel avg: 122d · This submission: 130d
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 K132191.
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
ZIP MIS INTERSPINOUS FUSION SYSTEM
K133091 · Aurora Spine · Nov 2013
AFFIX II SPINOUS PROCESS PLATE SYSTEM
K132411 · Nu Vasive, Incorporated · Nov 2013
UNIVISE SPINOUS PROCESS FIXATION PLATE (35MM, 40MM)
K132968 · Stryker Spine · Nov 2013
SPECTRUM SPINE SPINOUS PROCESS DEVICE
K130066 · Spectrum Spine IP Holdings, LLC · Nov 2013