Cleared Traditional

K040947 - DURASUL BIPOLAR

K040947 is an FDA 510(k) clearance for DURASUL BIPOLAR, manufactured by Centerpulse Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code KWY cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K040947 · Centerpulse Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
137d
Days
Class 2
Risk

K040947 is an FDA 510(k) clearance for the DURASUL BIPOLAR. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by Centerpulse Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on August 27, 2004 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3390 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Centerpulse Orthopedics, Inc. devices

FDA 510(k) Submission Details - K040947

510(k) Number K040947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2004
Decision Date August 27, 2004
Days to Decision 137 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 122d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 89
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K040947.
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
SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM
K023743 · Smith & Nephew, Inc. · Jan 2003
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