FDA.reportPublic FDA data

510(k) K222700

Device
Tibial Baseplate, Tibial Insert
Applicant
United Orthopedic Corporation
510(k) number
K222700
Product code
JWH  
Decision
Substantially Equivalent (SESE)
Decision date
2022-10-06
Date received
2022-09-07
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
Lois Ho
Address
No 57, Park Ave. 2, Science Park Hsinchu City TW 30075 30075

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
K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.2026-09-04
K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.2026-09-01
K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc.2026-08-07
K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.2026-07-31
K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.2026-07-23
K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UC2026-06-25
K261032NovoKnee (SteriKnee)NovoSource2026-04-27
K253793Materialise TKA Guide SystemMaterialise NV2026-01-06
K252974EMPOWR KneeEncore Medical L.P.2025-12-19
K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UC2025-11-19
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

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases