Cleared Traditional

Footmotion Plating System (K161448) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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
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 Peers - HRS Plate, Fixation, Bone

All 696
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K161448.
Medline UNITE® Ankle Fracture Plating System
K162829 · Medline Industries, Inc. · Dec 2016
EVOS Small Fragment Plating System
K162078 · Smith & Nephew, Inc. · Nov 2016
VLP Wrist Fracture System
K161665 · Smith & Nephew, Inc. · Nov 2016
Ulna Plating System
K162424 · Biomet, Inc. · Oct 2016
BIOFOAM Bone Wedge
K152062 · Wrightmedicaltechnologyinc · May 2016
Cable-Ready Cable Grip System: Cable-Ready Bone Plate System
K151716 · Zimmer, Inc. · Jan 2016