Cleared Traditional

EBA One Nailing System (K183666) - FDA 510(k) Clearance

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

K183666 · Citieffe S.R.L. · Orthopedic device
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Nov 2019
Decision
322d
Days
Class 2
Risk

K183666 is an FDA 510(k) clearance for the EBA One Nailing System. 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 November 14, 2019 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K183666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2018
Decision Date November 14, 2019
Days to Decision 322 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
200d slower than avg
Panel avg: 122d · This submission: 322d
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 261
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K183666.
Affixus(R) Natural Nail(R) System Humeral Nail
K200814 · Zimmer GmbH · Apr 2020
T2 Alpha Tibia Nailing System, IMN Screws System
K193308 · Stryker Trauma GmbH · Feb 2020
TTC Phantom® Intramedullary Nail System
K192163 · Paragon 28, Inc. · Jan 2020
Zimmer Natural Nail System Cephalomedullary Nails
K192312 · Zimmer GmbH · Oct 2019
Pediatric Nailing PlatformFemur
K190321 · OrthoPediatrics Corp. · Oct 2019
PRECICE System
K191336 · Nuvasive Specialized Orthopedics, Inc. · Sep 2019