Cleared Special

K023302 - ECHELON POROUS PLUS HA HIP STEMS

K023302 is an FDA 510(k) clearance for ECHELON POROUS PLUS HA HIP STEMS, manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with product code MEH cleared through the Special 510(k) pathway after a 22-day FDA review.

K023302 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
22d
Days
Class 2
Risk

K023302 is an FDA 510(k) clearance for the ECHELON POROUS PLUS HA HIP STEMS. Classified as Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (product code MEH), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on October 25, 2002 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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 - K023302

510(k) Number K023302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2002
Decision Date October 25, 2002
Days to Decision 22 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
100d faster than avg
Panel avg: 122d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

MEH Device Classification - Class 2, Special Controls

Product Code MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

All 159
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K023302.
EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS
K040613 · Exactech, Inc. · Jun 2004
MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM
K032641 · Portland Orthopaedics Pty. , Ltd. · Jan 2004
ACCOLADE-J HIP STEM SERIES
K032300 · Howmedica Osteonics Corp. · Oct 2003
ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM
K023102 · Howmedica Osteonics Corp. · Oct 2002
HA MALLORY/HEAD POROUS FEMORAL STEM & HA MALLORY/HEAD POROUS LATERALIZED FEMORAL STEM
K021403 · Biomet Orthopedics, Inc. · May 2002
SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMS
K020615 · Howmedica Osteonics Corp. · May 2002
K023302 · ECHELON POROUS PLUS HA HIP STEMS
Download PDF FDA Summary Smith & Nephew, Inc.