Cleared Traditional

K173935 - Mediant Anterior Cervical Plating System

K173935 is an FDA 510(k) clearance for Mediant Anterior Cervical Plating System, manufactured by Intelligent Implant Systems, LLC. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K173935 · Intelligent Implant Systems, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2018
Decision
111d
Days
Class 2
Risk

K173935 is an FDA 510(k) clearance for the Mediant Anterior Cervical Plating System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Intelligent Implant Systems, LLC (Charlotte, US). The FDA issued a Cleared decision on April 16, 2018 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 Intelligent Implant Systems, LLC devices

FDA 510(k) Submission Details - K173935

510(k) Number K173935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2017
Decision Date April 16, 2018
Days to Decision 111 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
11d faster than avg
Panel avg: 122d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWQ Device Classification - Class 2, Special Controls

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 481
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K173935.
Vail ALIF Buttress Plate System
K180755 · Evolution Spine, LLC · Jul 2018
Life Spine Lumbar Fixation System (SENTRY)
K180166 · Life Spine, Inc. · Jun 2018
Cure™ Lumbar Plate System
K180090 · Meditech Spine, LLC · Apr 2018
Axis Anterior Cervical Plate System
K173867 · Axis Orthopaedics · Apr 2018
Genesys Spine Binary Lumbar Plate System
K173885 · Genesys Spine · Apr 2018
Zavation Buttress Plate System
K180537 · Zavation Medical Products, LLC · Mar 2018