Cleared Abbreviated

SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (POROUS COATED) (K032108) - FDA 510(k) Clearance

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

K032108 · Aesculap, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jan 2004
Decision
191d
Days
Class 2
Risk

K032108 is an FDA 510(k) clearance for the SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (POROUS COATED). Classified as Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (product code MBH), Class II - Special Controls.

Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on January 15, 2004 after a review of 191 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3565 - 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 Aesculap, Inc. devices

Submission Details

510(k) Number K032108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2003
Decision Date January 15, 2004
Days to Decision 191 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
69d slower than avg
Panel avg: 122d · This submission: 191d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code MBH Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3565
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 - MBH Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer

All 106
Devices cleared under the same product code (MBH) and FDA review panel - the closest regulatory comparables to K032108.
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K033489 · Biomet, Inc. · Jun 2004
SCORPIO TOTAL KNEE SYSTEM WITH PERI-APATITE COATING
K033971 · Howmedica Osteonics Corp. · May 2004
SCORPIO TOTAL KNEE SYSTEM
K033972 · Howmedica Osteonics Corp. · Apr 2004
GENESIS II POROUS PLUS HA KNEE SYSTEM
K032683 · Smith & Nephew, Inc. · Oct 2003
NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS
K031061 · Zimmer, Inc. · Oct 2003
DURACON TOTAL KNEE SYSTEM
K032163 · Howmedica Osteonics Corp. · Sep 2003