Cleared Special

K033769 - EIUS UNICOMPARTMENTAL KNEE SYSTEM

K033769 is an FDA 510(k) clearance for EIUS UNICOMPARTMENTAL KNEE SYSTEM, manufactured by Howmedica Osteonics Corp.. The device is a Class 2 Orthopedic device with product code HSX cleared through the Special 510(k) pathway after a 72-day FDA review.

K033769 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
72d
Days
Class 2
Risk

K033769 is an FDA 510(k) clearance for the EIUS UNICOMPARTMENTAL KNEE SYSTEM. Classified as Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (product code HSX), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on February 13, 2004 after a review of 72 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. 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 - K033769

510(k) Number K033769 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2003
Decision Date February 13, 2004
Days to Decision 72 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
50d faster than avg
Panel avg: 122d · This submission: 72d
Pathway characteristics
Modification to existing cleared device.

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 114
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K033769.
MAKO SURGICAL UNICONDYLAR KNEE SYSTEM
K060017 · Mako Surgical Corp. · Feb 2006
UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS
K050373 · Arthrosurface, Inc. · Oct 2005
UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD
K043570 · Conformis, Inc. · Mar 2005
ZIMMER UNICOMPARTMENTAL KNEE SYSTEM
K033363 · Zimmer, Inc. · Jan 2004
STELKAST UNICONDYLAR KNEE SYSTEM
K032824 · Stelkast Company · Nov 2003
HLS UNI EVOLUTION PROSTHESIS
K022211 · Tornier · May 2003
K033769 · EIUS UNICOMPARTMENTAL KNEE SYSTEM
Download PDF FDA Summary Howmedica Osteonics C…