Cleared Traditional

K113848 - R3 XLPE LINERS

K113848 is the FDA 510(k) clearance for R3 XLPE LINERS by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code MBL) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K113848 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
120d
Days
Class 2
Risk

K113848 is an FDA 510(k) clearance for the R3 XLPE 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 April 27, 2012 after a review of 120 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 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 K113848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2011
Decision Date April 27, 2012
Days to Decision 120 days
Submission Type Traditional
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
2d faster than avg
Panel avg: 122d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K113848.
R3 Anteverted Liners
K182535 · Smith & Nephew, Inc. · Nov 2018
OXINIUM DH Fermoral Heads
K161233 · Smith & Nephew, Inc. · Dec 2016
DYNASTY BIOFOAM SHELL
K122382 · Wrightmedicaltechnologyinc · Oct 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
R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS
K092386 · Smith & Nephew, Inc. · Nov 2009