Cleared Abbreviated

K092386 - R3 MULTI-HOLE SHELLS AND 36MM XLPE ACET...

K092386 is the FDA 510(k) clearance for R3 MULTI-HOLE SHELLS AND 36MM XLPE ACET... by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code MBL) cleared through the Abbreviated 510(k) pathway after a 90-day FDA review.

K092386 · Smith & Nephew, Inc. · Orthopedic device
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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
Combination Product No
PCCP Authorized No
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.

Regulatory Peers - MBL Prosthesis, Hip, Semi-constrained, Uncemented, Metal/polymer, Porous

All 11
Devices cleared under the same product code (MBL) and FDA review panel - the closest regulatory comparables to K092386.
R3 XLPE LINERS
K113848 · Smith & Nephew, Inc. · Apr 2012
R3 XLPE ANTEVERTED LINERS
K102370 · Smith & Nephew, Inc. · Jan 2011
COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS
K093363 · Smith & Nephew, Inc. · Jan 2010
SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM
K070756 · Smith & Nephew, Inc. · Jun 2007
REFLECTION 3 ACETABULAR SYSTEM
K061253 · Smith & Nephew, Inc. · May 2006
REFLECTION DUAL DIMENSION SHELL
K960094 · Smith & Nephew Richards, Inc. · Mar 1996