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FDA 510(k)

U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella

K-Number: K243656 · 2025-07-31

ApplicantUnited Orthopedic Corporation
Decision Date2025-07-31
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella is the device name listed in this FDA 510(k) record. The listed applicant is United Orthopedic Corporation. It received FDA 510(k) clearance on 2025-07-31 under 510(k) number K243656. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella?

U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella is a medical device that received FDA 510(k) clearance on 2025-07-31. The listed applicant is United Orthopedic Corporation. The 510(k) number is K243656.

When did U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella receive FDA 510(k) clearance?

U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella received FDA 510(k) clearance on 2025-07-31, under 510(k) number K243656.

Who is the listed applicant for U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella?

The FDA 510(k) record lists United Orthopedic Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella?

The FDA product code for U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella is MBH.

Other records listing United Orthopedic Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252725Stem Extension Line (U2 Total Knee System—PSA Type)K252303Stem Extension Line (USTAR II System)K242315Resolve Modular Revision Hip StemK243466Conformity Stem Extension Line, #0K243024Cellbrick Knee SpacerK242249Conformity Stem Extension Line

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Related Devices (Code: MBH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp.

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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