FDA.reportPublic FDA data

510(k) K240327

Device
UNIKO PointCloud? Knee Instruments
Applicant
Unik Orthopedics, Inc.
510(k) number
K240327
Product code
JWH
Decision
Substantially Equivalent (SESE)
Decision date
2024-06-27
Date received
2024-02-02
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
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Charlie Chi
Address
701 Fortune Dr., Unit E San Jose CA US 95131 95131

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JWH#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UC2026-06-25
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K253793Materialise TKA Guide SystemMaterialise NV2026-01-06
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K253314Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc.2025-10-29
K253144Freedom® Total Knee System – Titan PCK ComponentsMaxx Orthopedics, Inc.2025-10-22
K252725Stem Extension Line (U2 Total Knee System—PSA Type)United Orthopedic Corporation2025-09-25
K251554Materialise TKA Guide SystemMaterialise NV2025-07-14
K251776EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)Encore Medical L.P.2025-07-08
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
K242410NextStep Arthropedix Total Knee SystemNextstep Arthropedix2025-05-08
K250889EXULT Knee Replacement SystemCorentec Co., Ltd.2025-04-17
K250677LEGION Total Knee SystemSmith & Nephew, Inc.2025-04-02