Cleared Traditional

K230416 - Triathlon® Hinge Knee System (FDA 510(k) Clearance)

Also includes:
Triathlon® Revision Insert X3®

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230416 · Stryker · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2023
Decision
92d
Days
Class 2
Risk

K230416 is an FDA 510(k) clearance for the Triathlon® Hinge Knee System. Classified as Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (product code KRO), Class II - Special Controls.

Submitted by Stryker (Mahwah, US). The FDA issued a Cleared decision on May 19, 2023 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3510 - 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 devices

Submission Details

510(k) Number K230416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2023
Decision Date May 19, 2023
Days to Decision 92 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
30d faster than avg
Panel avg: 122d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3510
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 - KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

All 85
Devices cleared under the same product code (KRO) and FDA review panel - the closest regulatory comparables to K230416.
Triathlon® Tritanium® Asymmetric Patella
K252898 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Dec 2025
Stem Extension Line (USTAR II System)
K252303 · United Orthopedic Corporation · Aug 2025
Triathlon® Hinge Knee System
K251665 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Jul 2025
ATTUNE™ Revision Hinge Knee
K242871 · Depuy Ireland UC · Nov 2024
EVOLUTION® Hinge Knee System
K240043 · Microport Orthopedics, Inc. · Apr 2024
ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System
K233980 · Depuy Ireland UC · Mar 2024