Cleared Traditional

K040225 - OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM

K040225 is an FDA 510(k) clearance for OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM, manufactured by Osteoimplant Technology, Inc.. The device is a Class 2 Orthopedic device with product code KWZ cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K040225 · Osteoimplant Technology, Inc. · Orthopedic device
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May 2004
Decision
94d
Days
Class 2
Risk

K040225 is an FDA 510(k) clearance for the OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM. Classified as Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer (product code KWZ), Class II - Special Controls.

Submitted by Osteoimplant Technology, Inc. (Hunt Valley, US). The FDA issued a Cleared decision on May 6, 2004 after a review of 94 days - within the typical 510(k) review window.

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 Osteoimplant Technology, Inc. devices

FDA 510(k) Submission Details - K040225

510(k) Number K040225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2004
Decision Date May 06, 2004
Days to Decision 94 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 122d · This submission: 94d
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 32
Devices cleared under the same product code (KWZ) and FDA review panel - the closest regulatory comparables to K040225.
PINNACLE CONSTRAINED ACETABULAR LINERS
K052079 · DePuy Orthopaedics, Inc. · Oct 2005
PINNACLE CONSTRAINED ACETABULAR LINERS
K043058 · Depuy, Inc. · Mar 2005
EXACTECH ACUMATCH A-SERIES & MCS CONSTRAINED ACETABULAR LINERS
K040601 · Exactech, Inc. · Oct 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