Cleared Special

ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM (K030373) - FDA 510(k) Clearance

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

K030373 · Centerpulse Orthopedics, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 2003
Decision
30d
Days
Class 2
Risk

K030373 is an FDA 510(k) clearance for the ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Centerpulse Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on March 6, 2003 after a review of 30 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.

View all Centerpulse Orthopedics, Inc. devices

Submission Details

510(k) Number K030373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2003
Decision Date March 06, 2003
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 291
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K030373.
MODIFICATION TO DEPUY CERAMIC FEMORAL HEAD
K040644 · DePuy Orthopaedics, Inc. · Apr 2004
DEPUY CERAMIC FEMORAL HEADS
K031803 · DePuy Orthopaedics, Inc. · Jul 2003
ALUMINA CERAMIC FEMORAL HEADS, 28 AND 32 MM
K030724 · Zimmer, Inc. · Jun 2003
ALUMINA V40 FEMORAL HEADS
K023901 · Howmedica Osteonics Corp. · Jan 2003
GMRS PRESS FIT STEMS WITH PUREFIX HA
K022403 · Howmedica Osteonics Corp. · Oct 2002
RESTORATION MODULAR SYSTEM
K022549 · Howmedica Osteonics Corp. · Sep 2002