Cleared Traditional

K151118 - Smith and Nephew Legion Hinge Knee System

K151118 is an FDA 510(k) clearance for Smith and Nephew Legion Hinge Knee System, manufactured by Smith & Nephew. The device is a Class 2 Orthopedic device with product code KRO cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K151118 · Smith & Nephew · Orthopedic device
Download Printable Device Report (PDF)
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Jul 2015
Decision
92d
Days
Class 2
Risk

K151118 is an FDA 510(k) clearance for the Smith and Nephew Legion Hinge Knee System. Classified as Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (product code KRO), Class II - Special Controls.

Submitted by Smith & Nephew (Cordova, US). The FDA issued a Cleared decision on July 28, 2015 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3510 - 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 - K151118

510(k) Number K151118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2015
Decision Date July 28, 2015
Days to Decision 92 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
30d faster than avg
Panel avg: 122d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRO Device Classification - Class 2, Special Controls

Product Code KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3510
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 - KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

All 72
Devices cleared under the same product code (KRO) and FDA review panel - the closest regulatory comparables to K151118.
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