Cleared Traditional

K072121 - TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER

K072121 is an FDA 510(k) clearance for TRABECULAR METAL ACETABULAR REVISION SY..., 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 159-day FDA review.

K072121 · Zimmer, Inc. · Orthopedic device
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Jan 2008
Decision
159d
Days
Class 2
Risk

K072121 is an FDA 510(k) clearance for the TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER. 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 January 7, 2008 after a review of 159 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 - K072121

510(k) Number K072121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2007
Decision Date January 07, 2008
Days to Decision 159 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
37d slower than avg
Panel avg: 122d · This submission: 159d
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 K072121.
SMITH & NEPHEW RJ CONSTRAINED LINERS
K111635 · Smith & Nephew, Inc. · Sep 2011
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS
K101730 · Zimmer, Inc. · Dec 2010
R3 CONSTRAINED LINER, CONSTRAINED LINER
K083566 · Smith & Nephew, Inc. · Mar 2009
DEPUY SPA POROUS COATED PROXIMAL SLEEVE
K071059 · DePuy Orthopaedics, Inc. · Nov 2007
EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS
K071676 · Exactech, Inc. · Jul 2007
TRILOGY LONGEVITY CONSTRAINED LINER
K071718 · Zimmer, Inc. · Jul 2007