Cleared Traditional

Estremo Fibular Nail (K250197) - FDA 510(k) Clearance

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

K250197 · Citieffe S.R.L. · Orthopedic device
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Oct 2025
Decision
267d
Days
Class 2
Risk

K250197 is an FDA 510(k) clearance for the Estremo Fibular Nail. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Citieffe S.R.L. (Calderara Di Reno, IT). The FDA issued a Cleared decision on October 17, 2025 after a review of 267 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 Citieffe S.R.L. devices

Submission Details

510(k) Number K250197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2025
Decision Date October 17, 2025
Days to Decision 267 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
145d slower than avg
Panel avg: 122d · This submission: 267d
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 Peers - HSB Rod, Fixation, Intramedullary And Accessories

All 260
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K250197.
T2 Alpha Femur Retrograde Nailing System
K253640 · Stryker GmbH · Feb 2026
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K252826 · Jeil Medical Corporation · Dec 2025
DynaNail TTC Fusion System
K250628 · MedShape, Inc. · Sep 2025
T2 Alpha Humerus Nailing System
K251400 · Stryker GmbH · Aug 2025
T2 Alpha Femur Retrograde Nailing System
K250163 · Stryker GmbH · Aug 2025