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FDA 510(k)

U2 Total Knee System E-XPE products

K-Number: K161705 · 2017-03-16

ApplicantUnited Orthopedic Corporation
Decision Date2017-03-16
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

U2 Total Knee System E-XPE products is a medical device manufactured by United Orthopedic Corporation. It received FDA 510(k) clearance on 2017-03-16 under approval number K161705. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the U2 Total Knee System E-XPE products?

U2 Total Knee System E-XPE products is a medical device that received FDA 510(k) clearance on 2017-03-16. It is manufactured by United Orthopedic Corporation. The 510(k) number is K161705.

When was U2 Total Knee System E-XPE products approved by the FDA?

U2 Total Knee System E-XPE products received FDA 510(k) clearance on 2017-03-16, under approval number K161705.

What company makes U2 Total Knee System E-XPE products?

U2 Total Knee System E-XPE products is manufactured by United Orthopedic Corporation.

What is the FDA product code for U2 Total Knee System E-XPE products?

The FDA product code for U2 Total Knee System E-XPE products is JWH.

Related Clinical Trials

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Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 40246726 [Brief Discussion on the General Requirements of Quality Management System of Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025)

Other Devices by United Orthopedic Corporation

K152430All Poly Tibial Component K152439U2 Bipolar Implant and 22mm Femoral Head K152530UCP Stem K172251UTS Stem K170089U-Motion II Acetabular System— Additional sizes K163441Locking Cage, Full XPE Cup

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Related Devices (Code: JWH)

K160515PS2 Knee SystemConsensus Orthopedics, Inc. K160771Destiknee Total Knee SystemMeril Healthcare Private Limited K160157LOSPA Modular Knee SystemCorentec Co., Ltd. K162273Materialise TKA Guide SystemMaterialise NV K162422Klassic Knee SystemTotal Joint Orthopedics, Inc. K161945EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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