Cleared Traditional

K133052 - AFFIX NEXT GEN SPINOUS PROCESS PLATE SY...

K133052 is the FDA 510(k) clearance for AFFIX NEXT GEN SPINOUS PROCESS PLATE SY... by Nuvasive, Inc.. It is a Class 2 Orthopedic device (product code PEK) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K133052 · Nuvasive, Inc. · Orthopedic device
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Dec 2013
Decision
84d
Days
Class 2
Risk

K133052 is an FDA 510(k) clearance for the AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEM. Classified as Spinous Process Plate (product code PEK), Class II - Special Controls.

Submitted by Nuvasive, Inc. (San Diego, US). The FDA issued a Cleared decision on December 20, 2013 after a review of 84 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 Nuvasive, Inc. devices

Submission Details

510(k) Number K133052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2013
Decision Date December 20, 2013
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 27
Devices cleared under the same product code (PEK) and FDA review panel - the closest regulatory comparables to K133052.
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
SP-FIX SPINOUS PROCESS FIXATION PLATE
K132191 · Globus Medical, Inc. · 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