Cleared Abbreviated

K092386 - R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS (FDA 510(k) Clearance)

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

K092386 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2009
Decision
90d
Days
Class 2
Risk

K092386 is an FDA 510(k) clearance for the R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS. Classified as Prosthesis, Hip, Semi-constrained, Uncemented, Metal/polymer, Porous (product code MBL), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on November 3, 2009 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - the FDA orthopedic device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Smith & Nephew, Inc. devices

Submission Details

510(k) Number K092386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2009
Decision Date November 03, 2009
Days to Decision 90 days
Submission Type Abbreviated
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Standards-based clearance path.

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.