Cleared Traditional

K142502 - ALIANS ULNA LOCKING PLATING SYSTEM

K142502 is an FDA 510(k) clearance for ALIANS ULNA LOCKING PLATING SYSTEM, manufactured by Newclip Technics. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K142502 · Newclip Technics · Orthopedic device
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Dec 2014
Decision
109d
Days
Class 2
Risk

K142502 is an FDA 510(k) clearance for the ALIANS ULNA LOCKING PLATING SYSTEM. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Newclip Technics (Haute-Goulaine, FR). The FDA issued a Cleared decision on December 23, 2014 after a review of 109 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 Newclip Technics devices

FDA 510(k) Submission Details - K142502

510(k) Number K142502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2014
Decision Date December 23, 2014
Days to Decision 109 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
13d faster than avg
Panel avg: 122d · This submission: 109d
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 Consultant

The OrthoMedix Group, Inc.
J.D. Webb

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HRS Plate, Fixation, Bone

All 1216
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K142502.
Acumed Small Fragment Base Set
K143394 · Acumed, LLC · Jan 2015
Nitinol Compression Plating System
K143023 · Biomedical Enterprises, Inc. · Jan 2015
Arthrex Fracture System
K143139 · Arthrex, Inc. · Jan 2015
AxSOS 3 Ti Locking Plate System
K143138 · Stryker Trauma AG · Dec 2014
VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws
K143050 · Smith & Nephew, Inc. · Dec 2014
Mini and Micro Fragments Reconstruction System-NEOFIX
K142419 · Neoortho Productos Orthopedicos S/A · Dec 2014