Cleared Traditional

K063423 - TRIATHLON CS (CONDYLAR STABILIZING) LIPPED INSERT

K063423 is an FDA 510(k) clearance for TRIATHLON CS (CONDYLAR STABILIZING) LIP..., manufactured by Howmedica Osteonics. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K063423 · Howmedica Osteonics · Orthopedic device
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Jan 2007
Decision
70d
Days
Class 2
Risk

K063423 is an FDA 510(k) clearance for the TRIATHLON CS (CONDYLAR STABILIZING) LIPPED INSERT. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Howmedica Osteonics (Mahwah, US). The FDA issued a Cleared decision on January 22, 2007 after a review of 70 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. 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 Howmedica Osteonics devices

FDA 510(k) Submission Details - K063423

510(k) Number K063423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2006
Decision Date January 22, 2007
Days to Decision 70 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 122d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWH Device Classification - Class 2, Special Controls

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 847
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