Cleared Traditional

K223528 - Triathlon Hinge Knee System

K223528 is the FDA 510(k) clearance for Triathlon Hinge Knee System by Howmedica Osteonics Corp., Dba Stryker Orthopaedics. It is a Class 2 Orthopedic device (product code KRO) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K223528 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2023
Decision
58d
Days
Class 2
Risk

K223528 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 Howmedica Osteonics Corp., Dba Stryker Orthopaedics (Mahwah, US). The FDA issued a Cleared decision on January 20, 2023 after a review of 58 days - a notably fast clearance cycle.

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: 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 Corp., Dba Stryker Orthopaedics devices

Submission Details

510(k) Number K223528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2022
Decision Date January 20, 2023
Days to Decision 58 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
64d faster than avg
Panel avg: 122d · This submission: 58d
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 68
Devices cleared under the same product code (KRO) and FDA review panel - the closest regulatory comparables to K223528.
EVOLUTION® Hinge Knee System
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Triathlon® Hinge Knee System
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Modular Rotating Hinge Knee Systems and Compatible Components
K223069 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Apr 2023
LINK Endo-Model EVO Knee System
K220628 · Waldemar Link GmbH & Co. KG · May 2022
ELEOS Limb Salvage System
K211677 · Onkos Surgical · Jul 2021
LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE
K211768 · Waldemar Link GmbH & Co. KG · Jun 2021