Cleared Special

K042883 - SIZE 1 TRIATHLON CRUCIATE RETAINING (CR...

K042883 is the FDA 510(k) clearance for SIZE 1 TRIATHLON CRUCIATE RETAINING (CR... by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Special 510(k) pathway after a 35-day FDA review.

K042883 · Howmedica Osteonics Corp. · Orthopedic device
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Nov 2004
Decision
35d
Days
Class 2
Risk

K042883 is an FDA 510(k) clearance for the SIZE 1 TRIATHLON CRUCIATE RETAINING (CR) TIBIAL INSERT. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on November 23, 2004 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - 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 Howmedica Osteonics Corp. devices

Submission Details

510(k) Number K042883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2004
Decision Date November 23, 2004
Days to Decision 35 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
87d faster than avg
Panel avg: 122d · This submission: 35d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
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 - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 778
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K042883.
SCORPIO NRG KNEE SYSTEM
K042343 · Howmedica Osteonics Corp. · Feb 2005
TRIATHLON POSTERIORLY STABILIZED (PS) FEMORAL COMPONENT
K042993 · Howmedica Osteonics Corp. · Jan 2005
AEQUOS
K033260 · Aap Implantate AG · Dec 2004
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K042271 · Zimmer, Inc. · Oct 2004
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K041591 · Howmedica Osteonics Corp. · Sep 2004