Cleared Abbreviated

K052426 - SMITH & NEPHEW MODULAR HIP

K052426 is an FDA 510(k) clearance for SMITH & NEPHEW MODULAR HIP, manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with product code MEH cleared through the Abbreviated 510(k) pathway after a 96-day FDA review.

K052426 · Smith & Nephew, Inc. · Orthopedic device
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Dec 2005
Decision
96d
Days
Class 2
Risk

K052426 is an FDA 510(k) clearance for the SMITH & NEPHEW MODULAR HIP. Classified as Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (product code MEH), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on December 7, 2005 after a review of 96 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 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

FDA 510(k) Submission Details - K052426

510(k) Number K052426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2005
Decision Date December 07, 2005
Days to Decision 96 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
26d faster than avg
Panel avg: 122d · This submission: 96d
Pathway characteristics
Standards-based clearance path.

MEH Device Classification - Class 2, Special Controls

Product Code MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
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 - MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

All 152
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K052426.
RESTORATION ADM SYSTEM
K072020 · Howmedica Osteonics Corp. · Oct 2007
EXCIA TOTAL HIP SYSTEM WITH U-CAP
K060437 · Aesculap, Inc. · Mar 2006
SHORT CITATION FEMORAL STEM
K053528 · Stryker Orthopaedics · Jan 2006
BICONTACT HIP SYSTEM WITH U-CAP
K043079 · Aesculap · Dec 2004
SMITH & NEPHEW MODULAR HIP
K042127 · Smith & Nephew, Inc. · Nov 2004
FURLONG H-AC TOTAL HIP REPLACEMENT SYSTEM
K041353 · Jri Manufacturing, Ltd. · Oct 2004