Cleared Traditional

K140876 - VIEW PLATING SYSTEM

K140876 is an FDA 510(k) clearance for VIEW PLATING SYSTEM, manufactured by Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K140876 · Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jul 2014
Decision
106d
Days
Class 2
Risk

K140876 is an FDA 510(k) clearance for the VIEW PLATING SYSTEM,REDUCE FRACTURE PLATING SYSTEM,BONE SCREW. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic (Boonton, US). The FDA issued a Cleared decision on July 22, 2014 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic devices

FDA 510(k) Submission Details - K140876

510(k) Number K140876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2014
Decision Date July 22, 2014
Days to Decision 106 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
16d faster than avg
Panel avg: 122d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 1046
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K140876.
VARIAX 2 SYSTEM
K141992 · Stryker Trauma AG · Aug 2014
PEDILOC FRAGMENT SYSTEM
K140431 · OrthoPediatrics Corp. · Jul 2014
LINOS MOH HAND PLATING SYSTEM
K141489 · KLS-Martin L.P. · Jul 2014
VARIAX ELBOW PLATING SYSTEM
K141677 · Stryker Trauma AG · Jul 2014
VARIAX DISTAL RADIUS PLATING SYSTEM
K141430 · Stryker Leibinger GmbH & Co KG · Jul 2014
MAXLOCK EXTREME ELBOW FRACTURE SYSTEM
K141301 · Orthohelix Surgical Designs, Inc. · Jul 2014