{"product_id":"fda-510k-k252044-triathlon-total-knee-system-triathlon-gold-femoral-components","title":"FDA 510(k) K252044, Triathlon® Total Knee System - Triathlon® Gold Femoral Components, by Howmedica Osteonics Corp., Dba Stryker Orthopaedics","description":"\u003cp\u003eFDA 510(k) records for \u003cstrong\u003eTriathlon® Total Knee System - Triathlon® Gold Femoral Components\u003c\/strong\u003e (K252044), submitted by Howmedica Osteonics Corp., Dba Stryker Orthopaedics.\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003e510(k) Number:\u003c\/strong\u003e K252044\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDevice Classification:\u003c\/strong\u003e Prosthesis, Knee, Patello\/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer\/Metal\/Polymer\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Howmedica Osteonics Corp., Dba Stryker Orthopaedics\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDate Received:\u003c\/strong\u003e 06\/30\/2025\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 10\/24\/2025\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRegulation Number:\u003c\/strong\u003e 888.3565\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eProduct Code:\u003c\/strong\u003e MBH\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSubsequent Product Code:\u003c\/strong\u003e JWH\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRegulation Medical Specialty:\u003c\/strong\u003e Orthopedic\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eReview Panel:\u003c\/strong\u003e Orthopedic\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eTotal Pages:\u003c\/strong\u003e 3923 (3655 unredacted, 6% redacted overall)\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003cstrong\u003eWhat's in this document\u003c\/strong\u003e (sections may appear in any order):\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003e— \u003cstrong\u003e510(k) Summary \/ Statement:\u003c\/strong\u003e no distinct section found\u003c\/li\u003e\n\u003cli\u003e— \u003cstrong\u003eIndications for Use:\u003c\/strong\u003e no distinct section found\u003c\/li\u003e\n\u003cli\u003e— \u003cstrong\u003eDevice Description:\u003c\/strong\u003e no distinct section found\u003c\/li\u003e\n\u003cli\u003e— \u003cstrong\u003eSubstantial Equivalence \/ Predicate:\u003c\/strong\u003e no distinct section found\u003c\/li\u003e\n\u003cli\u003e— \u003cstrong\u003ePerformance \/ Bench Testing:\u003c\/strong\u003e no distinct section found\u003c\/li\u003e\n\u003cli\u003e— \u003cstrong\u003eBiocompatibility:\u003c\/strong\u003e no distinct section found\u003c\/li\u003e\n\u003cli\u003e— \u003cstrong\u003eSoftware \/ Cybersecurity:\u003c\/strong\u003e no distinct section found\u003c\/li\u003e\n\u003cli\u003e— \u003cstrong\u003eSterilization \/ Shelf Life:\u003c\/strong\u003e no distinct section found\u003c\/li\u003e\n\u003cli\u003e— \u003cstrong\u003eLabeling \/ IFU:\u003c\/strong\u003e no distinct section found\u003c\/li\u003e\n\u003cli\u003e— \u003cstrong\u003eClinical Data:\u003c\/strong\u003e no distinct section found\u003c\/li\u003e\n\u003cli\u003e— \u003cstrong\u003eFDA Correspondence:\u003c\/strong\u003e no distinct section found\u003c\/li\u003e\n\u003cli\u003e— \u003cstrong\u003eRisk Analysis \/ FMEA:\u003c\/strong\u003e no distinct section found\u003c\/li\u003e\n\u003cli\u003e— \u003cstrong\u003eElectromagnetic Compatibility (EMC):\u003c\/strong\u003e no distinct section found\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003cem\u003eSection contents and redaction percentages are AI-assisted estimates based on automated document analysis. Actual content may vary.\u003c\/em\u003e\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51454814519460,"sku":"FDA510K252044","price":299.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400","url":"https:\/\/foiadocs.com\/products\/fda-510k-k252044-triathlon-total-knee-system-triathlon-gold-femoral-components","provider":"FOIA Document Source","version":"1.0","type":"link"}