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510(k) K252044

Triathlon® Total Knee System - Triathlon® Gold Femoral Components by Howmedica Osteonics Corp., Dba Stryker Orthopaedics — Product Code MBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2025
Date Received
June 30, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3565
Review Panel
OR
Submission Type

Other clearances by Howmedica Osteonics Corp., Dba Stryker Orthopaedics

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  • 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 MBH

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  • K253637 — Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing I (February 18, 2026)
  • K253239 — Active-V Total Knee System; World Total Knee System (December 23, 2025)
  • K253161 — Balanced Knee System TriMax Porous Femoral Components (December 19, 2025)
  • K252777 — Freedom Metaphyseal Cone Implants (Metaphyseal Cones) (October 31, 2025)
  • K243656 — U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella (July 31, 2025)
  • K250980 — Physica System (Physica CR Porous Femoral components) (May 22, 2025)
  • K243768 — iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System (March 27, 2025)
  • K241597 — Freedom® Total Knee System - Porous Tibial Base Plate (February 13, 2025)