Cleared Traditional

K141571 - ORTHOFIX ANKLE HINDFOOT NAILING SYSTEM

K141571 is an FDA 510(k) clearance for ORTHOFIX ANKLE HINDFOOT NAILING SYSTEM, manufactured by Orthofix Srl. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K141571 · Orthofix Srl · Orthopedic device
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Nov 2014
Decision
153d
Days
Class 2
Risk

K141571 is an FDA 510(k) clearance for the ORTHOFIX ANKLE HINDFOOT NAILING SYSTEM. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Orthofix Srl (Lewisville, US). The FDA issued a Cleared decision on November 12, 2014 after a review of 153 days - an extended review cycle.

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 Orthofix Srl devices

FDA 510(k) Submission Details - K141571

510(k) Number K141571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2014
Decision Date November 12, 2014
Days to Decision 153 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
31d slower than avg
Panel avg: 122d · This submission: 153d
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 461
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K141571.
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INS HILDEN TIBIAL ARZZT
K133166 · Truemed Group, LLC · Nov 2014
ZIMMER M/DN INTRAMEDULLARY FIXATION SYSTEM
K142281 · Zimmer, Inc. · Oct 2014
VALOR Hindfoot Fusion Nail System
K142602 · Wrightmedicaltechnologyinc · Oct 2014