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510(k) K252898

Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper by Howmedica Osteonics Corp., Dba Stryker Orthopaedics — Product Code KRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2025
Date Received
September 11, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3510
Review Panel
OR
Submission Type

Other clearances by Howmedica Osteonics Corp., Dba Stryker Orthopaedics

  • K253637 — Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing I (February 18, 2026)
  • K252044 — Triathlon® Total Knee System - Triathlon® Gold Femoral Components (October 24, 2025)
  • K251665 — Triathlon® Hinge Knee System (July 25, 2025)
  • K243784 — Stryker Orthopaedics Hip Devices Labeling Update (February 6, 2025)
  • K243817 — Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Po (February 6, 2025)
  • K242831 — Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Tr (December 4, 2024)
  • K241716 — Global Modular Replacement System, Modular Replacement System, Modular Rotating (August 2, 2024)
  • K234025 — 22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads (April 24, 2024)
  • K240418 — Stryker Orthopaedics Hip Systems Labeling Update (April 12, 2024)
  • K233724 — 28mm/38D MDM X3 Insert for MDM Liner (March 11, 2024)

Other clearances for product code KRO

  • K252303 — Stem Extension Line (USTAR II System) (August 22, 2025)
  • K251665 — Triathlon® Hinge Knee System (July 25, 2025)
  • K242871 — ATTUNE™ Revision Hinge Knee (November 21, 2024)
  • K240043 — EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Fe (April 1, 2024)
  • K233980 — ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation S (March 21, 2024)
  • K230563 — EVOLUTION® Hinge Knee System (September 27, 2023)
  • K230416 — Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® (May 19, 2023)
  • K223069 — Modular Rotating Hinge Knee Systems and Compatible Components (April 21, 2023)
  • K223528 — Triathlon® Hinge Knee System (January 20, 2023)
  • K220628 — LINK Endo-Model EVO Knee System (May 3, 2022)