Cleared Traditional

K163653 - NOVOS-NAIL Limb Lengthening System (LLS)

K163653 is an FDA 510(k) clearance for NOVOS-NAIL Limb Lengthening System (LLS), manufactured by Smith & Nephew. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 294-day FDA review.

K163653 · Smith & Nephew · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Smith & Nephew devices

FDA 510(k) Submission Details - K163653

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.

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 Peers - HSB Rod, Fixation, Intramedullary And Accessories

All 366
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K163653.
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K172114 · Zimmer, Inc. · Aug 2017
ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System
K161466 · Orthofix Srl · Jan 2017