Cleared Special

K033442 - REFLECTION CONSTRAINED LINER

K033442 is an FDA 510(k) clearance for REFLECTION CONSTRAINED LINER, manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with product code KWZ cleared through the Special 510(k) pathway after a 28-day FDA review.

K033442 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K033442

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.

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 33
Devices cleared under the same product code (KWZ) and FDA review panel - the closest regulatory comparables to K033442.
PINNACLE CONSTRAINED ACETABULAR LINERS
K043058 · Depuy, Inc. · Mar 2005
EXACTECH ACUMATCH A-SERIES & MCS CONSTRAINED ACETABULAR LINERS
K040601 · Exactech, Inc. · Oct 2004
OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM
K040225 · Osteoimplant Technology, Inc. · May 2004
EPSILON DURASUL CONSTRAINED ACETABULAR LINER
K030923 · Centerpulse Orthopedics, Inc. · Oct 2003
CONSTRAINED LINER
K023794 · Encore Medical, L.P. · Apr 2003
FREEDOM CONSTRAINED LINERS
K030047 · Biomet, Inc. · Jan 2003
K033442 · REFLECTION CONSTRAINED LINER
Download PDF FDA Summary Smith & Nephew, Inc.