Cleared Traditional

K170012 - Foot and Hand Motion

K170012 is the FDA 510(k) clearance for Foot and Hand Motion by Newclip Technics. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K170012 · Newclip Technics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
111d
Days
Class 2
Risk

K170012 is an FDA 510(k) clearance for the Foot and Hand Motion. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Newclip Technics (Haute-Goulaine, FR). The FDA issued a Cleared decision on April 24, 2017 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 K170012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2017
Decision Date April 24, 2017
Days to Decision 111 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
11d faster than avg
Panel avg: 122d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 573
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K170012.
Arthrex Compression Screws
K170382 · Arthrex, Inc. · May 2017
CAPTIVATE™ Compression Screws
K162825 · Globus Medical, Inc. · May 2017
HV Screw System
K170889 · Wrightmedicaltechnologyinc · Apr 2017
MICATM Screw System
K162353 · Wrightmedicaltechnologyinc · Apr 2017
DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw
K161616 · Synthes USA Products, LLC · Feb 2017
KLS Martin Cannulated Headless Screws
K161259 · KLS-Martin L.P. · Dec 2016