Cleared Traditional

K142217 - Reliance Interspinous Plate System

K142217 is the FDA 510(k) clearance for Reliance Interspinous Plate System by Reliance Medical Systems, LLC. It is a Class 2 Orthopedic device (product code PEK) cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K142217 · Reliance Medical Systems, LLC · Orthopedic device
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Apr 2015
Decision
233d
Days
Class 2
Risk

K142217 is an FDA 510(k) clearance for the Reliance Interspinous Plate System. Classified as Spinous Process Plate (product code PEK), Class II - Special Controls.

Submitted by Reliance Medical Systems, LLC (Bountiful, US). The FDA issued a Cleared decision on April 2, 2015 after a review of 233 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.

View all Reliance Medical Systems, LLC devices

Submission Details

510(k) Number K142217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2014
Decision Date April 02, 2015
Days to Decision 233 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
111d slower than avg
Panel avg: 122d · This submission: 233d
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 K142217.
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