Cleared Traditional

K141103 - INTRAMEDULLARY NAIL AND SCREWS-NEONAIL

K141103 is an FDA 510(k) clearance for INTRAMEDULLARY NAIL AND SCREWS-NEONAIL, manufactured by Neoortho Produtos Ortopedicos S/A. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K141103 · Neoortho Produtos Ortopedicos S/A · Orthopedic device
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Sep 2014
Decision
147d
Days
Class 2
Risk

K141103 is an FDA 510(k) clearance for the INTRAMEDULLARY NAIL AND SCREWS-NEONAIL. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Neoortho Produtos Ortopedicos S/A (San Diego, US). The FDA issued a Cleared decision on September 23, 2014 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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 Neoortho Produtos Ortopedicos S/A devices

FDA 510(k) Submission Details - K141103

510(k) Number K141103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2014
Decision Date September 23, 2014
Days to Decision 147 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
25d slower than avg
Panel avg: 122d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSB Device Classification - Class 2, Special Controls

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 379
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K141103.
ORTHOFIX ANKLE HINDFOOT NAILING SYSTEM
K141571 · Orthofix Srl · Nov 2014
ZIMMER M/DN INTRAMEDULLARY FIXATION SYSTEM
K142281 · Zimmer, Inc. · Oct 2014
VALOR Hindfoot Fusion Nail System
K142602 · Wrightmedicaltechnologyinc · Oct 2014
AOS 6.5MM CAPTURED, FULLY THREADED CANCELLOUS SCREW
K141228 · Advanced Orthopaedic Solutions, Inc. · Jul 2014
SYNTHES SYNSONIC ULNA NAIL
K131984 · Synthes (Usa) · Mar 2014
SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEM
K131548 · Synthes USA Products, LLC · Feb 2014