Cleared Traditional

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) - FDA 510(k) Clearance

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

K171320 · Meril Healthcare Pvt. , Ltd. · Orthopedic device
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Mar 2018
Decision
308d
Days
Class 2
Risk

K171320 is an FDA 510(k) clearance for the ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, AR.... Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Meril Healthcare Pvt. , Ltd. (Muktanand Marg, Chala, Vapi, IN). The FDA issued a Cleared decision on March 8, 2018 after a review of 308 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Meril Healthcare Pvt. , Ltd. devices

Submission Details

510(k) Number K171320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2017
Decision Date March 08, 2018
Days to Decision 308 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
186d slower than avg
Panel avg: 122d · This submission: 308d
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

Empirical Testing Corp
Meredith May

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 698
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K171320.
Anchorage Bone Plating System
K172148 · Stryker GmbH · Mar 2018
PYTHON Plate Trial Instruments
K173930 · Treace Medical Concepts, Inc. · Mar 2018
TDM Plate and Screw System
K171808 · Tdm Co., Ltd. · Mar 2018
Activmotion Range
K173746 · Newclip Technics · Feb 2018
Osteotomy Truss System (OTS)
K172294 · 4Web, Inc. · Feb 2018
Activ Ankle
K173641 · Newclip Technics · Jan 2018