Cleared Traditional

ZIMMER UNICOMPARTMENTAL KNEE SYSTEM (K033363) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K033363 · Zimmer, Inc. · Orthopedic device
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Jan 2004
Decision
87d
Days
Class 2
Risk

K033363 is an FDA 510(k) clearance for the ZIMMER UNICOMPARTMENTAL KNEE SYSTEM. Classified as Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (product code HSX), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on January 16, 2004 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3520 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Zimmer, Inc. devices

Submission Details

510(k) Number K033363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2003
Decision Date January 16, 2004
Days to Decision 87 days
Submission Type Traditional
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
35d faster than avg
Panel avg: 122d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3520
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 - HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer

All 69
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K033363.
COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE
K061779 · Smith & Nephew, Inc. · Aug 2006
COMPETITOR UNICONDYLAR KNEE TIBIAL BASEPLATE
K061011 · Smith & Nephew, Inc. · Jul 2006
EIUS UNICOMPARTMENTAL KNEE SYSTEM
K033769 · Howmedica Osteonics Corp. · Feb 2004
MODIFICATION TO MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM (8 MM ARTICULAR SURFACE)
K010685 · Zimmer, Inc. · Apr 2001
FIRST STEP UNICOMPARTMENTAL KNEE SYSTEM
K992287 · Howmedica Osteonics Corp. · Nov 1999
ETHYLENE OXIDE STERILIZATION OF POLYETHYLENE ORTHOPEDIC DEVICES
K952068 · Zimmer, Inc. · Sep 1995