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510(k) K161705

Device
U2 Total Knee System E-XPE Products
Applicant
UNITED ORTHOPEDIC CORPORATION
510(k) number
K161705
Product code
JWH  
Decision
Substantially Equivalent (SESE)
Decision date
2017-03-16
Date received
2016-06-20
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
KAREN HO
Address
No 57, Park Ave. 2, Science Park Hsinchu TW 300 300

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
K262057GMK ExtensionMedacta International SA2026-09-15
K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts2026-09-11
K262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.2026-09-10
K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.2026-09-08
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

Legacy Summary#

summary

FDA Review#

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