Cleared Traditional

K033363 - ZIMMER UNICOMPARTMENTAL KNEE SYSTEM

K033363 is an FDA 510(k) clearance for ZIMMER UNICOMPARTMENTAL KNEE SYSTEM, manufactured by Zimmer, Inc.. The device is a Class 2 Orthopedic device with product code HSX cleared through the Traditional 510(k) pathway after a 87-day FDA review.

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

FDA 510(k) Submission Details - K033363

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.

HSX Device Classification - Class 2, Special Controls

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 101
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K033363.
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STELKAST UNICONDYLAR KNEE SYSTEM
K032824 · Stelkast Company · Nov 2003
HLS UNI EVOLUTION PROSTHESIS
K022211 · Tornier · May 2003
SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE
K011954 · Sulzer Orthopedics, Inc. · Sep 2001