Cleared Traditional

K162641 - Smith & Nephew, Inc. R3™ Constrained Liner (FDA 510(k) Clearance)

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

K162641 · Smith & Nephew, Inc. · Orthopedic device
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Jun 2017
Decision
270d
Days
Class 2
Risk

K162641 is an FDA 510(k) clearance for the Smith & Nephew, Inc. R3™ Constrained Liner. Classified as Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer (product code KWZ), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Cordova, US). The FDA issued a Cleared decision on June 19, 2017 after a review of 270 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3310 - 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, Inc. devices

Submission Details

510(k) Number K162641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2016
Decision Date June 19, 2017
Days to Decision 270 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
148d slower than avg
Panel avg: 122d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3310
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.