Cleared Traditional

K252898 - Triathlon® Tritanium® Asymmetric Patella

Also marketed or referenced as:
Triathlon® Tritanium® Symmetric Patella Triathlon® Symmetric Patella Triathlon® Asymmetric Patella Scorpio® Universal Dome Patella Triathlon® Hinge Bumper

K252898 is an FDA 510(k) clearance for Triathlon Tritanium Asymmetric Patella, manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The device is a Class 2 Orthopedic device with product code KRO cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K252898 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2025
Decision
95d
Days
Class 2
Risk

K252898 is an FDA 510(k) clearance for the Triathlon® Tritanium® Asymmetric Patella. 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 December 15, 2025 after a review of 95 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 Howmedica Osteonics Corp., Dba Stryker Orthopaedics devices

FDA 510(k) Submission Details - K252898

510(k) Number K252898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2025
Decision Date December 15, 2025
Days to Decision 95 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
27d faster than avg
Panel avg: 122d · This submission: 95d
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 K252898.
Triathlon® Knee System
K261898 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Aug 2026
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