Cleared Traditional

NOVOS-NAIL Limb Lengthening System (LLS) (K163653) - FDA 510(k) Clearance

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

K163653 · Smith & Nephew · Orthopedic device
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Oct 2017
Decision
294d
Days
Class 2
Risk

K163653 is an FDA 510(k) clearance for the NOVOS-NAIL Limb Lengthening System (LLS). Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Smith & Nephew (Memphis, US). The FDA issued a Cleared decision on October 13, 2017 after a review of 294 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.

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Submission Details

510(k) Number K163653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2016
Decision Date October 13, 2017
Days to Decision 294 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
172d slower than avg
Panel avg: 122d · This submission: 294d
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 263
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K163653.
Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt
K172189 · Truemed Group, LLC · Jan 2018
T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System
K172774 · Stryker Trauma GmbH · Jan 2018
AUTOBAHN Nailing System
K171108 · Globus Medical, Inc. · Dec 2017
Zimmer Natural Nail System
K172114 · Zimmer, Inc. · Aug 2017
TRIGEN Low Profile Bone Screws
K161264 · Smith & Nephew, Inc. · Nov 2016
Affixus Tibial Nailing System
K150867 · Biomet, Inc. · Jun 2015