Cleared Traditional

K172326 - Triathlon Total Knee System

K172326 is the FDA 510(k) clearance for Triathlon Total Knee System by Stryker Orthopaedics. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K172326 · Stryker Orthopaedics · Orthopedic device
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Oct 2017
Decision
90d
Days
Class 2
Risk

K172326 is an FDA 510(k) clearance for the Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Stryker Orthopaedics (Mahwah, US). The FDA issued a Cleared decision on October 30, 2017 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker Orthopaedics devices

Submission Details

510(k) Number K172326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2017
Decision Date October 30, 2017
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 775
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K172326.
Unity Total Knee System
K173884 · Corin U.S.A. Limited · Jan 2018
Smith & Nephew Patient Matched Cutting Blocks
K172336 · Smith & Nephew, Inc. · Jan 2018
JOURNEY II XR Knee Instruments
K173331 · Smith & Nephew, Inc. · Nov 2017
MyKnee PPS-Pin Positioners
K170106 · Medacta International S.A. · Oct 2017
3DMetal Tibial Cones
K170149 · Medacta International S.A. · Aug 2017
EVOLUTION Revision CCK System
K171389 · Microport Orthopedics, Inc. · Aug 2017