Cleared Traditional

K143631 - Benefix Interspinous Fixation System

K143631 is the FDA 510(k) clearance for Benefix Interspinous Fixation System by U&I Corporation. It is a Class 2 Orthopedic device (product code PEK) cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K143631 · U&I Corporation · Orthopedic device
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Sep 2015
Decision
255d
Days
Class 2
Risk

K143631 is an FDA 510(k) clearance for the Benefix Interspinous Fixation System. Classified as Spinous Process Plate (product code PEK), Class II - Special Controls.

Submitted by U&I Corporation (Uijeongbu-Si, KR). The FDA issued a Cleared decision on September 3, 2015 after a review of 255 days - an extended review 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: 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.

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Submission Details

510(k) Number K143631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2014
Decision Date September 03, 2015
Days to Decision 255 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
133d slower than avg
Panel avg: 122d · This submission: 255d
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 29
Devices cleared under the same product code (PEK) and FDA review panel - the closest regulatory comparables to K143631.
SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System
K180156 · Globus Medical, Inc. · Mar 2018
SeaSpine Spinous Process System
K173334 · SeaSpine Orthopedics Corporation · Feb 2018
Spinal Elements' Spinous Process Plate System
K160465 · Spinal Elements, Inc. · Jul 2016
Affix IIS Spinous Process Plate System
K143388 · Nu Vasive, Incorporated · Mar 2015
AILERON INTERSPINOUS FIXATION SYSTEM
K140236 · Life Spine, Inc. · Oct 2014
VIA SPINOUS PROCESS FIXATION SYSTEM
K142213 · Spineology, Inc. · Sep 2014