Cleared Abbreviated

K023743 - SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

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

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
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 98
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K023743.
b-ONE® Bipolar Head
K253357 · B-One Ortho, Corp. · Apr 2026
Maxx Libertas Bipolar Hip Head (Bipolar Hip)
K243634 · Maxx Orthopedics, Inc. · Aug 2025
CORAIL Cemented Femoral Stem
K231526 · Depuy Ireland UC · Dec 2023
SpaceFlex Acetabular Cup
K223441 · G21, S.R.L. · Mar 2023
Vario-Cup System
K221794 · Waldemar Link GmbH & Co. KG · Jul 2022