Cleared Abbreviated

K072417 - SMITH & NEPHEW MIS HIP STEM

K072417 is the FDA 510(k) clearance for SMITH & NEPHEW MIS HIP STEM by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code LPH) cleared through the Abbreviated 510(k) pathway after a 135-day FDA review.

K072417 · Smith & Nephew, Inc. · Orthopedic device
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Jan 2008
Decision
135d
Days
Class 2
Risk

K072417 is an FDA 510(k) clearance for the SMITH & NEPHEW MIS HIP STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on January 10, 2008 after a review of 135 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 K072417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2007
Decision Date January 10, 2008
Days to Decision 135 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
13d slower than avg
Panel avg: 122d · This submission: 135d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 442
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K072417.
TRITANIUM ACETABULAR SHELL SYSTEM
K081171 · Howmedica Osteonics Corp. · Jul 2008
ECHELON TITANIUM HIP SYSTEM
K072817 · Smith & Nephew, Inc. · May 2008
SMITH & NEPHEW MIS HIP STEM WITH STIKTITE
K080625 · Smith & Nephew, Inc. · May 2008
REVELATION AND LINEAR HIP STEMS AND FMP ACETABULAR SHELLS (SPIKED, HEMISPHERICAL AND FLARED)
K072888 · Encore Medical, L.P. · Jan 2008
DEPUY PINNACLE ALTRX ACETABULAR LINERS
K072963 · DePuy Orthopaedics, Inc. · Jan 2008
FOUNDATION (FMP) POROUS COATED SPIKED ACETABULAR SYSTEM
K072154 · Encore Medical, L.P. · Dec 2007