Cleared Traditional

NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS Plating System (K150561) - FDA 510(k) Clearance

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

K150561 · Narang Medical Limited · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2015
Decision
264d
Days
Class 2
Risk

K150561 is an FDA 510(k) clearance for the NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NE.... Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Narang Medical Limited (New Delhi, IN). The FDA issued a Cleared decision on November 25, 2015 after a review of 264 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 Narang Medical Limited devices

Submission Details

510(k) Number K150561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2015
Decision Date November 25, 2015
Days to Decision 264 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
142d slower than avg
Panel avg: 122d · This submission: 264d
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 K150561.
BIOFOAM Bone Wedge
K152062 · Wrightmedicaltechnologyinc · May 2016
Cable-Ready Cable Grip System: Cable-Ready Bone Plate System
K151716 · Zimmer, Inc. · Jan 2016
ORTHOLOC® 3Di Foot Plating Reconstruction System
K152974 · Wrightmedicaltechnologyinc · Dec 2015
VLP Mini-Mod Talus Plates
K152976 · Smith & Nephew, Inc. · Nov 2015
TOTAL COMPRESSION PLATING (TCP) SYSTEM
K151442 · Wrightmedicaltechnologyinc · Sep 2015
Arthrex Fracture Plates
K151732 · Arthrex, Inc. · Aug 2015