Cleared Abbreviated

K021803 - REFLECTION CONSTRAINED LINER

K021803 is the FDA 510(k) clearance for REFLECTION CONSTRAINED LINER by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code KWZ) cleared through the Abbreviated 510(k) pathway after a 199-day FDA review.

K021803 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
199d
Days
Class 2
Risk

K021803 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 December 19, 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Smith & Nephew, Inc. devices

Submission Details

510(k) Number K021803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2002
Decision Date December 19, 2002
Days to Decision 199 days
Submission Type Abbreviated
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
Standards-based clearance path.

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 31
Devices cleared under the same product code (KWZ) and FDA review panel - the closest regulatory comparables to K021803.
CONSTRAINED LINER
K023794 · Encore Medical, L.P. · Apr 2003
FREEDOM CONSTRAINED LINERS
K030047 · Biomet, Inc. · Jan 2003
TRILOGY ACETABULAR SYSTEM CONSTRAINED LINER, MODEL 6154 SERIES
K021826 · Zimmer, Inc. · Dec 2002
RINGLOC CONSTRAINED LINERS
K021661 · Biomet Orthopedics, Inc. · Oct 2002
RINGLOC CONSTRAINED LINERS II
K021728 · Biomet, Inc. · Oct 2002
RINGLOC CONSTRAINED LINER
K950202 · Biomet, Inc. · May 1995