Cleared Traditional

K082371 - SMITH & NEPHEW SL-PLUS MIA STANDARD AND...

K082371 is the FDA 510(k) clearance for SMITH & NEPHEW SL-PLUS MIA STANDARD AND... by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code LZO) cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K082371 · Smith & Nephew, Inc. · Orthopedic device
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Feb 2009
Decision
175d
Days
Class 2
Risk

K082371 is an FDA 510(k) clearance for the SMITH & NEPHEW SL-PLUS MIA STANDARD AND LATERAL FEMORAL HIP STEM. 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. (Memphis, US). The FDA issued a Cleared decision on February 9, 2009 after a review of 175 days - an extended review cycle.

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 K082371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2008
Decision Date February 09, 2009
Days to Decision 175 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
53d slower than avg
Panel avg: 122d · This submission: 175d
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 427
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K082371.
44MM E1 ACETABULAR LINER WITH 44MM BIOLOX DELTA OPTION CERAMIC HEAD OR 44MM M A MAGNUM
K093549 · Biomet Manufacturing Corp · Dec 2009
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K083762 · Smith & Nephew, Inc. · Mar 2009
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA C
K083558 · Medacta International S.A. · Mar 2009
BIOLOX DELTA OPTION CERAMIC HEADS
K082996 · Biomet, Inc. · Jan 2009
NOVATION 12/14 CEMENTED FEMORAL STEMS
K083392 · Exactech, Inc. · Dec 2008
BIOLOX DELTA CERAMIC FEMORAL HEAD, BIOLOX DELTA CERAMIC FEMORAL HEAD OFFSET SLEEVE
K082844 · Encore Medical, L.P. · Nov 2008