Cleared Traditional

K143096 - SL-PLUS MIA and SL-PLUS Femoral Stems w...

K143096 is the FDA 510(k) clearance for SL-PLUS MIA and SL-PLUS Femoral Stems w... by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code LZO) cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K143096 · Smith & Nephew, Inc. · Orthopedic device
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Mar 2015
Decision
147d
Days
Class 2
Risk

K143096 is an FDA 510(k) clearance for the SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HA. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Cordova, US). The FDA issued a Cleared decision on March 24, 2015 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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 K143096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2014
Decision Date March 24, 2015
Days to Decision 147 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
25d slower than avg
Panel avg: 122d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 421
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K143096.
POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA
K143739 · Smith & Nephew, Inc. · Apr 2015
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PROFEMUR Preserve Classic Stem
K150302 · Microport Orthopedics, Inc. · Apr 2015
MasterSL femoral stem
K143509 · Lima Corporate S.P.A. · Jan 2015
LINK MP RECONSTRUCTION PROSTHESIS
K142187 · Waldemar Link GmbH & Co. KG · Nov 2014
PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS
K141235 · Microport Orthopedics, Inc. · Sep 2014