Cleared Traditional

K152289 - Alians Elbow Locking Plating System

K152289 is an FDA 510(k) clearance for Alians Elbow 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 370-day FDA review.

K152289 · Newclip Technics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
370d
Days
Class 2
Risk

K152289 is an FDA 510(k) clearance for the Alians Elbow 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 August 17, 2016 after a review of 370 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K152289

510(k) Number K152289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2015
Decision Date August 17, 2016
Days to Decision 370 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
248d slower than avg
Panel avg: 122d · This submission: 370d
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 1251
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K152289.
OrthoPediatrics Locking Proximal Femur System Cortical Screws
K162307 · OrthoPediatrics Corp. · Sep 2016
ARIX Hand System
K161746 · Jeil Medical Corporation · Sep 2016
Additive Orthopaedics Bone Wedge System
K153207 · Additive Orthopaedics, LLC · Sep 2016
Tarsa-Link Stand-Alone Wedge Fixation System
K161037 · Life Spine, Inc. · Aug 2016
Distal Radius Plating System
K161292 · Miami Device Solutions, LLC · Aug 2016
Converge
K153573 · Biomedical Enterprises, Inc. · Aug 2016