Cleared Traditional

K161448 - Footmotion Plating System

K161448 is the FDA 510(k) clearance for Footmotion Plating System by Newclip Technics. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K161448 · Newclip Technics · Orthopedic device
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Oct 2016
Decision
159d
Days
Class 2
Risk

K161448 is an FDA 510(k) clearance for the Footmotion 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 October 31, 2016 after a review of 159 days - an extended review cycle.

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

Submission Details

510(k) Number K161448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2016
Decision Date October 31, 2016
Days to Decision 159 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
37d slower than avg
Panel avg: 122d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 916
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K161448.
VLP Wrist Fracture System
K161665 · Smith & Nephew, Inc. · Nov 2016
LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer
K161703 · Aap Implantate AG · Nov 2016
MatrixRIB Fixation System
K161590 · Synthes USA Products, LLC · Nov 2016
Ulna Plating System
K162424 · Biomet, Inc. · Oct 2016
OrthoPediatrics Locking Proximal Femur System Cortical Screws
K162307 · OrthoPediatrics Corp. · Sep 2016
ARIX Hand System
K161746 · Jeil Medical Corporation · Sep 2016