FDA.reportPublic FDA data

510(k) K250889

Device
EXULT Knee Replacement System
Applicant
Corentec Co., Ltd.
510(k) number
K250889
Product code
JWH
Decision
Substantially Equivalent (SESE)
Decision date
2025-04-17
Date received
2025-03-25
Regulation
888.3560
Classification name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Sanghee Seo
Address
12, Yeongsanhong 1-Gil, Ipjang-Myeon, Seobuk-Gu, Cheonan-Si Chungchongnam-Do KR 31056 31056

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JWH#

510(k), Device, Applicant table
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K252725Stem Extension Line (U2 Total Knee System—PSA Type)United Orthopedic Corporation2025-09-25
K251554Materialise TKA Guide SystemMaterialise NV2025-07-14
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K251241EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)Encore Medical L.P.2025-07-02
K251717Freedom® Total Knee System – Titanium Tibial Base PlateMaxx Orthopedics, Inc.2025-06-26
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K250677LEGION Total Knee SystemSmith & Nephew, Inc.2025-04-02
K243991Klassic Knee System - Revision Tibial BaseplateTotal Joint Othopedics, Inc.2025-03-24
K250382Freedom Total Knee System (All-poly Tibial Plate)Maxx Orthopedics, Inc.2025-03-13