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FDA 510(k)

三鐙關節系統；三鐙專業後穩定股骨组件；三鐙鋼材底板；三鐙低輪廓胫骨托盤；三鐙金屬背板髌骨；三鐙部分關節系統；艾文髌股關節假體；Restoris多隔間關節系統

K 號：K242831 · 2024-12-04

申請人Howmedica Osteonics Corp., Dba Stryker Orthopaedics
決定日期2024-12-04
產品代碼JWH
諮詢委員會或
決定相當於

器材摘要

Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee System 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 2024-12-04 under 510(k) number K242831. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee System?

Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee System is a medical device that received FDA 510(k) clearance on 2024-12-04. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The 510(k) number is K242831.

When did Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee System receive FDA 510(k) clearance?

Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee System received FDA 510(k) clearance on 2024-12-04, under 510(k) number K242831.

Who is the listed applicant for Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee System?

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 Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee System?

The FDA product code for Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee System is JWH.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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K253637Triathlon® 全膝系統 - Triathlon® X3® 中間穩定胫骨承插件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

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相關器械（代碼：JWH）

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。

K262057GMK 扩充設備Medacta International SAK260063GSPE 分隔器The General Hospital Corporation, d/b/a MassachusettsK262293EVOLUTION MPX™ 全膝系統Suzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ 全膝系統修復水泥固定胫骨增強器、樹枝擴展和壓入式樹枝擴展B-One Ortho, Corp.K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.K253961SK膝關節系統Just Medical Devices (Tianjin) Co., Ltd.

官方來源

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