Cleared Special

K182535 - R3 Anteverted Liners (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K182535 · Smith & Nephew, Inc. · Orthopedic device
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Nov 2018
Decision
66d
Days
Class 2
Risk

K182535 is an FDA 510(k) clearance for the R3 Anteverted Liners. Classified as Prosthesis, Hip, Semi-constrained, Uncemented, Metal/polymer, Porous (product code MBL), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Cordova, US). The FDA issued a Cleared decision on November 19, 2018 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Smith & Nephew, Inc. devices

Submission Details

510(k) Number K182535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2018
Decision Date November 19, 2018
Days to Decision 66 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 122d · This submission: 66d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MBL Prosthesis, Hip, Semi-constrained, Uncemented, Metal/polymer, Porous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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.