Cleared Traditional

K230416 - Triathlon® Hinge Knee System

Also marketed or referenced as:
Triathlon® Revision Insert X3®

K230416 is an FDA 510(k) clearance for Triathlon Hinge Knee System, manufactured by Stryker. The device is a Class 2 Orthopedic device with product code KRO cleared through the Traditional 510(k) pathway after a 92-day FDA review.

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

FDA 510(k) Submission Details - K230416

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.

KRO Device Classification - Class 2, Special Controls

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 81
Devices cleared under the same product code (KRO) and FDA review panel - the closest regulatory comparables to K230416.
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
EVOLUTION® Hinge Knee System
K230563 · Microport Orthopedics, Inc. · Sep 2023
Modular Rotating Hinge Knee Systems and Compatible Components
K223069 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Apr 2023
Triathlon® Hinge Knee System
K223528 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Jan 2023
LINK Endo-Model EVO Knee System
K220628 · Waldemar Link GmbH & Co. KG · May 2022