Cleared Traditional

K030923 - EPSILON DURASUL CONSTRAINED ACETABULAR LINER

K030923 is an FDA 510(k) clearance for EPSILON DURASUL CONSTRAINED ACETABULAR ..., manufactured by Centerpulse Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code KWZ cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K030923 · Centerpulse Orthopedics, Inc. · Orthopedic device
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Oct 2003
Decision
193d
Days
Class 2
Risk

K030923 is an FDA 510(k) clearance for the EPSILON DURASUL CONSTRAINED ACETABULAR LINER. Classified as Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer (product code KWZ), Class II - Special Controls.

Submitted by Centerpulse Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on October 3, 2003 after a review of 193 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3310 - 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 - K030923

510(k) Number K030923 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2003
Decision Date October 03, 2003
Days to Decision 193 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
71d slower than avg
Panel avg: 122d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWZ Device Classification - Class 2, Special Controls

Product Code KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3310
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 - KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer

All 33
Devices cleared under the same product code (KWZ) and FDA review panel - the closest regulatory comparables to K030923.
EXACTECH ACUMATCH A-SERIES & MCS CONSTRAINED ACETABULAR LINERS
K040601 · Exactech, Inc. · Oct 2004
OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM
K040225 · Osteoimplant Technology, Inc. · May 2004
REFLECTION CONSTRAINED LINER
K033442 · Smith & Nephew, Inc. · Nov 2003
CONSTRAINED LINER
K023794 · Encore Medical, L.P. · Apr 2003
FREEDOM CONSTRAINED LINERS
K030047 · Biomet, Inc. · Jan 2003
TRILOGY ACETABULAR SYSTEM CONSTRAINED LINER, MODEL 6154 SERIES
K021826 · Zimmer, Inc. · Dec 2002