Cleared Special

REFLECTION CONSTRAINED LINER (K033442) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K033442 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
28d
Days
Class 2
Risk

K033442 is an FDA 510(k) clearance for the REFLECTION 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 November 26, 2003 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3310 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Smith & Nephew, Inc. devices

Submission Details

510(k) Number K033442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2003
Decision Date November 26, 2003
Days to Decision 28 days
Submission Type Special
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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 33
Devices cleared under the same product code (KWZ) and FDA review panel - the closest regulatory comparables to K033442.
Mpact Constrained Liner
K241461 · Medacta International S.A. · Jul 2025
PINNACLETM Constrained Acetabular Liners
K240639 · Depuy Ireland UC · Apr 2024
Smith & Nephew, Inc. R3™ Constrained Liner
K162641 · Smith & Nephew, Inc. · Jun 2017
EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture Bolt
K163497 · Encore Medical, L.P. · Mar 2017
SMITH & NEPHEW R3 CONSTRAINED LINERS
K122139 · Smith & Nephew, Inc. · Oct 2012
SMITH & NEPHEW RJ CONSTRAINED LINERS
K111635 · Smith & Nephew, Inc. · Sep 2011