Cleared Abbreviated

K102370 - R3 XLPE ANTEVERTED LINERS

K102370 is the FDA 510(k) clearance for R3 XLPE ANTEVERTED LINERS by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code MBL) cleared through the Abbreviated 510(k) pathway after a 152-day FDA review.

K102370 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
152d
Days
Class 2
Risk

K102370 is an FDA 510(k) clearance for the R3 XLPE ANTEVERTED 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 January 19, 2011 after a review of 152 days - an extended review cycle.

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 K102370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2010
Decision Date January 19, 2011
Days to Decision 152 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
30d slower than avg
Panel avg: 122d · This submission: 152d
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 K102370.
OXINIUM DH Fermoral Heads
K161233 · Smith & Nephew, Inc. · Dec 2016
DYNASTY BIOFOAM SHELL
K122382 · Wrightmedicaltechnologyinc · Oct 2012
R3 XLPE LINERS
K113848 · Smith & Nephew, Inc. · Apr 2012
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
SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM
K070756 · Smith & Nephew, Inc. · Jun 2007