Cleared Traditional

K132968 - UNIVISE SPINOUS PROCESS FIXATION PLATE (35MM, 40MM)

K132968 is an FDA 510(k) clearance for UNIVISE SPINOUS PROCESS FIXATION PLATE ..., manufactured by Stryker Spine. The device is a Class 2 Orthopedic device with product code PEK cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K132968 · Stryker Spine · Orthopedic device
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Nov 2013
Decision
56d
Days
Class 2
Risk

K132968 is an FDA 510(k) clearance for the UNIVISE SPINOUS PROCESS FIXATION PLATE (35MM, 40MM). Classified as Spinous Process Plate (product code PEK), Class II - Special Controls.

Submitted by Stryker Spine (Allendale, US). The FDA issued a Cleared decision on November 18, 2013 after a review of 56 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Stryker Spine devices

FDA 510(k) Submission Details - K132968

510(k) Number K132968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2013
Decision Date November 18, 2013
Days to Decision 56 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
66d faster than avg
Panel avg: 122d · This submission: 56d
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 K132968.
ZIP MIS INTERSPINOUS FUSION SYSTEM
K133091 · Aurora Spine · Nov 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
SPECTRUM SPINE SPINOUS PROCESS DEVICE
K130066 · Spectrum Spine IP Holdings, LLC · Nov 2013
INTEGRA INTERSPINOUS PROCESS SYSTEM
K121924 · Seaspine, Inc. · Sep 2013
SUREFIX INTERSPINOUS FUSION SYSTEM
K124014 · Jg Spine, LLC · Aug 2013