Cleared Abbreviated

K023743 - SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM

K023743 is the FDA 510(k) clearance for SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code KWY) cleared through the Abbreviated 510(k) pathway after a 77-day FDA review.

K023743 · Smith & Nephew, Inc. · Orthopedic device
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Jan 2003
Decision
77d
Days
Class 2
Risk

K023743 is an FDA 510(k) clearance for the SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on January 23, 2003 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3390 - 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 K023743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2002
Decision Date January 23, 2003
Days to Decision 77 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
45d faster than avg
Panel avg: 122d · This submission: 77d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3390
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 - KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

All 74
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K023743.
AESCULAP BIPOLAR ACETABULAR CUP
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K052990 · Biomet, Inc. · Dec 2005
PIVOT BIPOLAR FEMORAL HEAD
K050966 · Ortho Development Corp. · Jul 2005
MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS
K013211 · Exactech, Inc. · Dec 2001
ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS
K010081 · Exactech, Inc. · Feb 2001
M2A 32MM TAPER SYSTEM
K003363 · Biomet, Inc. · Dec 2000