Cleared Traditional

K201147 - Elos® Intramedullary Nailing System (FDA 510(k) Clearance)

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

K201147 · Intrauma S.P.A · Orthopedic device
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Jul 2021
Decision
446d
Days
Class 2
Risk

K201147 is an FDA 510(k) clearance for the Elos® Intramedullary Nailing System. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Intrauma S.P.A (Rivoli (To), IT). The FDA issued a Cleared decision on July 19, 2021 after a review of 446 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Intrauma S.P.A devices

Submission Details

510(k) Number K201147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2020
Decision Date July 19, 2021
Days to Decision 446 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
324d slower than avg
Panel avg: 122d · This submission: 446d
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

Mcra, LLC
Hollace Saas Rhodes

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 522
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K201147.
AUTOBAHN™ Nailing System
K261043 · Globus Medical, Inc. · Apr 2026
Arthrex Humeral Nails
K252016 · Arthrex, Inc. · Mar 2026
Fusion FibFix Nail
K252961 · Fusion Orthopedics USA, LLC · Mar 2026
Affixus Retrograde Femoral Nailing System
K253566 · Zimmer, Inc. · Mar 2026
Reselute Tibial Nail
K253517 · Reselute, Inc. · Mar 2026
Arthrex FibuLock Nail System
K252196 · Arthrex, Inc. · Mar 2026