Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

U2 Total Knee System, XPE Tibial Insert, PS PLUS

K-Number: K210961 · 2021-04-21

ApplicantUnited Orthopedic Corporation
Decision Date2021-04-21
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

U2 Total Knee System, XPE Tibial Insert, PS PLUS is a medical device manufactured by United Orthopedic Corporation. It received FDA 510(k) clearance on 2021-04-21 under approval number K210961. 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, XPE Tibial Insert, PS PLUS?

U2 Total Knee System, XPE Tibial Insert, PS PLUS is a medical device that received FDA 510(k) clearance on 2021-04-21. It is manufactured by United Orthopedic Corporation. The 510(k) number is K210961.

When was U2 Total Knee System, XPE Tibial Insert, PS PLUS approved by the FDA?

U2 Total Knee System, XPE Tibial Insert, PS PLUS received FDA 510(k) clearance on 2021-04-21, under approval number K210961.

What company makes U2 Total Knee System, XPE Tibial Insert, PS PLUS?

U2 Total Knee System, XPE Tibial Insert, PS PLUS is manufactured by United Orthopedic Corporation.

What is the FDA product code for U2 Total Knee System, XPE Tibial Insert, PS PLUS?

The FDA product code for U2 Total Knee System, XPE Tibial Insert, PS PLUS is JWH.

Related Clinical Trials

NCT07191067 Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty RECRUITING NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT06019832 Analysis of Varus Collapse in Obese Patients With Stem and Non-Stem Tibial Components Following Primary Total Knee Arthroplasty ACTIVE_NOT_RECRUITING NCT04325022 Safety and Effectiveness Study of OR3O™ Dual Mobility System in THA ACTIVE_NOT_RECRUITING

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)

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

View all 26 devices →

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.

↑