Cleared Traditional

K172699 - Agile Nail

K172699 is the FDA 510(k) clearance for Agile Nail by Orthofix Srl. It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 228-day FDA review.

K172699 · Orthofix Srl · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2018
Decision
228d
Days
Class 2
Risk

K172699 is an FDA 510(k) clearance for the Agile Nail. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Orthofix Srl (Bussolengo, IT). The FDA issued a Cleared decision on April 23, 2018 after a review of 228 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

Submission Details

510(k) Number K172699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2017
Decision Date April 23, 2018
Days to Decision 228 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
106d slower than avg
Panel avg: 122d · This submission: 228d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Wagoner Consulting, LLC
Cheryl Wagoner

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 - HSB Rod, Fixation, Intramedullary And Accessories

All 330
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K172699.
Apex Femoral Nailing System
K181375 · Orthoxel · Jul 2018
T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System
K180436 · Stryker Trauma GmbH · Jun 2018
OrthoPediatrics PediNail Intramedullary Platform
K172583 · Orthopediatrics, Inc. · May 2018
PRECICE STRYDE System
K180503 · Nuvasive Specialized Orthopedics, Inc. · Apr 2018
TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System
K173811 · In2bones Sas · Mar 2018
Talon DistalFix Humeral Nail
K173255 · Orthopedic Designs North America, Inc. · Feb 2018