Cleared Traditional

K162849 - Huvex Interspinous Fixation System

K162849 is an FDA 510(k) clearance for Huvex Interspinous Fixation System, manufactured by Dio Medical Co., Ltd.. The device is a Class 2 Orthopedic device with product code PEK cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K162849 · Dio Medical Co., Ltd. · Orthopedic device
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Feb 2017
Decision
128d
Days
Class 2
Risk

K162849 is an FDA 510(k) clearance for the Huvex Interspinous Fixation System. Classified as Spinous Process Plate (product code PEK), Class II - Special Controls.

Submitted by Dio Medical Co., Ltd. (Jungwon-Gu Sungnam-Si, KR). The FDA issued a Cleared decision on February 16, 2017 after a review of 128 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 Dio Medical Co., Ltd. devices

FDA 510(k) Submission Details - K162849

510(k) Number K162849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2016
Decision Date February 16, 2017
Days to Decision 128 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
6d slower than avg
Panel avg: 122d · This submission: 128d
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 35
Devices cleared under the same product code (PEK) and FDA review panel - the closest regulatory comparables to K162849.
AERIAL™ Interspinous Fixation
K180817 · Globus Medical, Inc. · May 2018
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
Precision Spine Interspinous Plate System
K160568 · Precision Spine, Inc. · May 2016
Benefix Interspinous Fixation System
K143631 · U&I Corporation · Sep 2015