Cleared Traditional

K083566 - R3 CONSTRAINED LINER

K083566 is the FDA 510(k) clearance for R3 CONSTRAINED LINER by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code KWZ) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K083566 · Smith & Nephew, Inc. · Orthopedic device
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Mar 2009
Decision
90d
Days
Class 2
Risk

K083566 is an FDA 510(k) clearance for the R3 CONSTRAINED LINER, CONSTRAINED LINER. Classified as Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer (product code KWZ), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on March 3, 2009 after a review of 90 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 Smith & Nephew, Inc. devices

Submission Details

510(k) Number K083566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2008
Decision Date March 03, 2009
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 30
Devices cleared under the same product code (KWZ) and FDA review panel - the closest regulatory comparables to K083566.
SMITH & NEPHEW R3 CONSTRAINED LINERS
K122139 · Smith & Nephew, Inc. · Oct 2012
SMITH & NEPHEW RJ CONSTRAINED LINERS
K111635 · Smith & Nephew, Inc. · Sep 2011
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS
K101730 · Zimmer, Inc. · Dec 2010
TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER
K072121 · Zimmer, Inc. · Jan 2008
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