Cleared Traditional

K221395 - Footmotion Plating System

K221395 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 49-day FDA review.

K221395 · Newclip Technics · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jul 2022
Decision
49d
Days
Class 2
Risk

K221395 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 July 1, 2022 after a review of 49 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 K221395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2022
Decision Date July 01, 2022
Days to Decision 49 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
73d faster than avg
Panel avg: 122d · This submission: 49d
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 903
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K221395.
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K221920 · Jeil Medical Corporation · Aug 2022
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Arthrex Mini Fragment System
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Baby Gorilla/Gorilla Plating System
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K221362 · Exremity Medical, LLC · Jun 2022