Cleared Special

K142867 - Reliance Posterior Cervical-Thoracic System

K142867 is an FDA 510(k) clearance for Reliance Posterior Cervical-Thoracic System, manufactured by Reliance Medical Systems, LLC. The device is a Class 2 Orthopedic device with product code KWP cleared through the Special 510(k) pathway after a 210-day FDA review.

K142867 · Reliance Medical Systems, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
210d
Days
Class 2
Risk

K142867 is an FDA 510(k) clearance for the Reliance Posterior Cervical-Thoracic System. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Reliance Medical Systems, LLC (Bountiful, US). The FDA issued a Cleared decision on April 29, 2015 after a review of 210 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K142867

510(k) Number K142867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2014
Decision Date April 29, 2015
Days to Decision 210 days
Submission Type Special
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
88d slower than avg
Panel avg: 122d · This submission: 210d
Pathway characteristics
Modification to existing cleared device.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 429
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K142867.
LnK Posterior Cervical Fixation System
K143278 · L & K Biomed Co., Ltd. · Jul 2015
OASYS System
K150753 · Stryker Corporation · Jun 2015
Sure Lok Mini Posterior Cervical/Upper Thoracic System
K150851 · Precision Spine, Inc. · Jun 2015
Streamline OCT Occipito-Cervico-Thoracic System
K150254 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · Apr 2015
SOLSTICE OCT System
K142253 · Life Spine, Inc. · Apr 2015
SOLSTICE OCT System
K143249 · Life Spine, Inc. · Apr 2015
K142867 · Reliance Posterior Cervical-Thoracic System
Download PDF FDA Summary Reliance Medical Syst…