Cleared Traditional

K143388 - Affix IIS Spinous Process Plate System

K143388 is an FDA 510(k) clearance for Affix IIS Spinous Process Plate System, manufactured by Nu Vasive, Incorporated. The device is a Class 2 Orthopedic device with product code PEK cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K143388 · Nu Vasive, Incorporated · Orthopedic device
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Mar 2015
Decision
99d
Days
Class 2
Risk

K143388 is an FDA 510(k) clearance for the Affix IIS Spinous Process Plate System. Classified as Spinous Process Plate (product code PEK), Class II - Special Controls.

Submitted by Nu Vasive, Incorporated (San Diego, US). The FDA issued a Cleared decision on March 5, 2015 after a review of 99 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 Nu Vasive, Incorporated devices

FDA 510(k) Submission Details - K143388

510(k) Number K143388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2014
Decision Date March 05, 2015
Days to Decision 99 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
23d faster than avg
Panel avg: 122d · This submission: 99d
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 K143388.
HA Minuteman G3 MIS Fusion Plate
K151741 · Spinal Simplicity, LLC · Aug 2015
Precision Spine Interspinous Plate System
K151863 · Precision Spine, Inc. · Aug 2015
Reliance Interspinous Plate System
K142217 · Reliance Medical Systems, LLC · Apr 2015
SPINOUS PROCESS FUSION (SPF) PLATE
K140046 · Spinal Simplicity, LLC · Jan 2015
Interspinous Plate System
K142378 · Precision Spine, Inc. · Dec 2014
ZIP MIS INTERSPINOUS FUSION SYSTEM
K141317 · Aurora Spine, Inc. · Nov 2014