Cleared Traditional

K233150 - NET BRAND Osteosynthesis Nailing System (FDA 510(k) Clearance)

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

K233150 · Narang Medical , Ltd. · Orthopedic device
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Feb 2024
Decision
146d
Days
Class 2
Risk

K233150 is an FDA 510(k) clearance for the NET BRAND Osteosynthesis Nailing System. Classified as Nail, Fixation, Bone (product code JDS), Class II - Special Controls.

Submitted by Narang Medical , Ltd. (Delhi, IN). The FDA issued a Cleared decision on February 20, 2024 after a review of 146 days - within the typical 510(k) review window.

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 , Ltd. devices

Submission Details

510(k) Number K233150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2023
Decision Date February 20, 2024
Days to Decision 146 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
24d slower than avg
Panel avg: 122d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDS Nail, 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 - JDS Nail, Fixation, Bone

All 52
Devices cleared under the same product code (JDS) and FDA review panel - the closest regulatory comparables to K233150.
TRIGEN Stable Lock Nut & Washer
K243608 · Smith & Nephew, Inc. · Jun 2025
TRIGEN MAX Tibial Nail System
K240061 · Smith & Nephew, Inc. · Sep 2024
TRIGEN INTERTAN 10S Nail System
K241804 · Smith & Nephew, Inc. · Aug 2024
TRIGEN META-NAIL Nail System
K230761 · Smith & Nephew, Inc. · Jun 2023
DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm
K201336 · Synthes USA Products, LLC · Sep 2020
Auxein Nailing System
K192003 · Auxein Medical Private Limited · Jun 2020