Cleared Traditional

K173746 - Activmotion Range

K173746 is the FDA 510(k) clearance for Activmotion Range by Newclip Technics. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K173746 · Newclip Technics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2018
Decision
81d
Days
Class 2
Risk

K173746 is an FDA 510(k) clearance for the Activmotion Range. 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 February 27, 2018 after a review of 81 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Newclip Technics devices

Submission Details

510(k) Number K173746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2017
Decision Date February 27, 2018
Days to Decision 81 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
41d faster than avg
Panel avg: 122d · This submission: 81d
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 914
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K173746.
PYTHON Plate Trial Instruments
K173930 · Treace Medical Concepts, Inc. · Mar 2018
TDM Plate and Screw System
K171808 · Tdm Co., Ltd. · Mar 2018
ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia and Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screws, ARMAR/ ARTISClavical Hook Plate & MBOSS/FIXION Screws, ARMAR/ ARTIS Metaphyseal Plate & MBOSS/FIXION Screws, ARMAR / ARTISCalcaneal Plate & MBOSS/FIXION Screws
K171320 · Meril Healthcare Pvt. , Ltd. · Mar 2018
Osteotomy Truss System (OTS)
K172294 · 4Web, Inc. · Feb 2018
Activ Ankle
K173641 · Newclip Technics · Jan 2018
EVOS Small Fragment Upper Extremity Plates
K173293 · Smith & Nephew, Inc. · Jan 2018