Cleared Traditional

K021826 - TRILOGY ACETABULAR SYSTEM CONSTRAINED LINER, MODEL 6154 SERIES

K021826 is an FDA 510(k) clearance for TRILOGY ACETABULAR SYSTEM CONSTRAINED LINER, manufactured by Zimmer, Inc.. The device is a Class 2 Orthopedic device with product code KWZ cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K021826 · Zimmer, Inc. · Orthopedic device
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Dec 2002
Decision
199d
Days
Class 2
Risk

K021826 is an FDA 510(k) clearance for the TRILOGY ACETABULAR SYSTEM CONSTRAINED LINER, MODEL 6154 SERIES. Classified as Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer (product code KWZ), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 20, 2002 after a review of 199 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 Zimmer, Inc. devices

FDA 510(k) Submission Details - K021826

510(k) Number K021826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2002
Decision Date December 20, 2002
Days to Decision 199 days
Submission Type Traditional
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
77d slower than avg
Panel avg: 122d · This submission: 199d
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 K021826.
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
REFLECTION CONSTRAINED LINER
K021803 · Smith & Nephew, Inc. · Dec 2002
RINGLOC CONSTRAINED LINERS
K021661 · Biomet Orthopedics, Inc. · Oct 2002
RINGLOC CONSTRAINED LINERS II
K021728 · Biomet, Inc. · Oct 2002