Cleared Abbreviated

K023743 - SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM

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

K023743 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K023743

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.

KWY Device Classification - Class 2, Special Controls

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 91
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K023743.
STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH REINFORCEMENT STEM
K052990 · Biomet, Inc. · Dec 2005
U1 HIP SYSTEM - BIPOLAR
K050269 · United Orthopedic Corp. · Aug 2005
PIVOT BIPOLAR FEMORAL HEAD
K050966 · Ortho Development Corp. · Jul 2005
FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH)
K014072 · Disc-O-Tech Medical Technologies, Ltd. · Mar 2002
MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS
K013211 · Exactech, Inc. · Dec 2001
ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS
K010081 · Exactech, Inc. · Feb 2001