FDA 510(k)

Triathlon® 全膝系統 - Triathlon® X3® 中間穩定胫骨承插件

K 號：K253637 · 2026-02-18

申請人Howmedica Osteonics Corp., Dba Stryker Orthopaedics

決定日期2026-02-18

產品代碼MBH

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決定相當於

器材摘要

Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. It received FDA 510(k) clearance on 2026-02-18 under 510(k) number K253637. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert?

Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert is a medical device that received FDA 510(k) clearance on 2026-02-18. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The 510(k) number is K253637.

When did Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert receive FDA 510(k) clearance?

Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert received FDA 510(k) clearance on 2026-02-18, under 510(k) number K253637.

Who is the listed applicant for Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert?

The FDA 510(k) record lists Howmedica Osteonics Corp., Dba Stryker Orthopaedics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert?

The FDA product code for Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert is MBH.

其他以 Howmedica Osteonics Corp., Dba Stryker Orthopaedics 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K261898Triathlon® 過膝系統；Triathlon® 開合膝關節系統；Scorpio® 全膝系統 K261624Omnifit® 20°系列I植入物；Omnifit® Crossfire® 10°系列II植入物；限制性 acetabular 植入物；Trident® Crossfire® 0°聚乙烯植入物；Trident® Crossfire® 10°聚乙烯植入物；System 12 Crossfire® 10°植入物；Trident® 0°限制性 acetabular 植入物；Trident® 限制性 acetabular 线圈；Trident® 全聚乙烯限制性 acetabular 植入物；Crossfire® 偏心植入物 10°；Artisan® 骨栓；UHR® 大頭雙極組件 K252898Triathlon® Tritanium® 非對稱膝蓋；Triathlon® 對稱膝蓋；Triathlon® 對稱膝蓋；Triathlon® 非對稱膝蓋；Scorpio® 適用型圓頂膝蓋；Triathlon® 鍵盤緩震器 K252044Triathlon® 全膝系統 - Triathlon® 金屬股骨组件 K251665Triathlon® 開合膝關節系統 K250989Stryker及Serf關節設備

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相關器械（代碼：MBH）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K261275Unity全膝系統，Unity膝水泥無縫股骨Corin, Ltd.K261462LANDMARK 全膝系統Smith & Nephew, Inc.K253728EVOLUTION® AM BIOFOAM® 道骨系統Microport Orthopedics, Inc.K251840齊默® 佩森娜® 適合個人化膝關節系統Zimmer, Inc.K253189Persona 個人化膝關節系統（Persona 多孔等离子喷涂 PPS 髋骨）Zimmer, Inc.K253328GMK 3D金屬胫骨托延伸器Medacta International S.A.

官方來源

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