Cleared Traditional

K252044 - Triathlon® Total Knee System - Triathlon® Gold Femoral Components

K252044 is an FDA 510(k) clearance for Triathlon Total Knee System - Triathlon..., manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The device is a Class 2 Orthopedic device with product code MBH cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K252044 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2025
Decision
116d
Days
Class 2
Risk

K252044 is an FDA 510(k) clearance for the Triathlon® Total Knee System - Triathlon® Gold Femoral Components. Classified as Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (product code MBH), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp., Dba Stryker Orthopaedics (Mahwah, US). The FDA issued a Cleared decision on October 24, 2025 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3565 - 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 Howmedica Osteonics Corp., Dba Stryker Orthopaedics devices

FDA 510(k) Submission Details - K252044

510(k) Number K252044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2025
Decision Date October 24, 2025
Days to Decision 116 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
6d faster than avg
Panel avg: 122d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MBH Device Classification - Class 2, Special Controls

Product Code MBH Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3565
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 - MBH Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer

All 140
Devices cleared under the same product code (MBH) and FDA review panel - the closest regulatory comparables to K252044.
Active-V Total Knee System
K253239 · Signature Orthopaedics Pty, Ltd. · Dec 2025
Balanced Knee System TriMax Porous Femoral Components
K253161 · Ortho Development Corp. · Dec 2025
Freedom Metaphyseal Cone Implants (Metaphyseal Cones)
K252777 · Maxx Orthopedics, Inc. · Oct 2025
U2 Total Knee System – PF+ Patella
K243656 · United Orthopedic Corporation · Jul 2025
Physica System (Physica CR Porous Femoral components)
K250980 · Lima Corporate S.P.A. · May 2025
iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System
K243768 · Restor3D, Inc. · Mar 2025