Cleared Traditional

K261189 - Freedom Nail Ankle Fusion System

K261189 is an FDA 510(k) clearance for Freedom Nail Ankle Fusion System, manufactured by McGinley Orthopaedic Innovations. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K261189 · McGinley Orthopaedic Innovations · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
192d
Days
Class 2
Risk

K261189 is an FDA 510(k) clearance for the Freedom Nail Ankle Fusion System. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by McGinley Orthopaedic Innovations (Casper, US). The FDA issued a Cleared decision on October 19, 2026 after a review of 192 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.

FDA 510(k) Submission Details - K261189

510(k) Number K261189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2026
Decision Date October 19, 2026
Days to Decision 192 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
70d slower than avg
Panel avg: 122d · This submission: 192d
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 Consultant

MCRA, LLC
Hannah Irwin

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 529
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K261189.
Pediatric Nailing Platform Femur
K261345 · OrthoPediatrics Corp. · Sep 2026
AND Medical Femoral Nail System (PFNA01)
K253080 · Suzhou and Science & Technology Development Corp. · Jun 2026
Precice™ Max System and Precice™ Ankle Salvage System
K261651 · NuVasive Specialized Orthopedics · Jun 2026
Fule Metallic Lockable Intramedullary Nail Systems
K253155 · Beijing Fule Science & Technology Development Co., Ltd. · Jun 2026
HERA Interlocking Intramedullary Nailing System
K253046 · ZheJiang Decans Medical Devices Co., Ltd. · Jun 2026
FITBONE® TRANSPORT AND LENGTHENING SYSTEM
K260146 · Orthofix Srl · May 2026
K261189 · Freedom Nail Ankle Fusion System
Download PDF FDA Summary McGinley Orthopaedic …