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FDA 510(k)

Stem Extension Line (USTAR II System)

K-Number: K252303 · 2025-08-22

ApplicantUnited Orthopedic Corporation
Decision Date2025-08-22
Product CodeKRO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Stem Extension Line (USTAR II System) is a medical device manufactured by United Orthopedic Corporation. It received FDA 510(k) clearance on 2025-08-22 under approval number K252303. The device is classified under product code KRO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stem Extension Line (USTAR II System)?

Stem Extension Line (USTAR II System) is a medical device that received FDA 510(k) clearance on 2025-08-22. It is manufactured by United Orthopedic Corporation. The 510(k) number is K252303.

When was Stem Extension Line (USTAR II System) approved by the FDA?

Stem Extension Line (USTAR II System) received FDA 510(k) clearance on 2025-08-22, under approval number K252303.

What company makes Stem Extension Line (USTAR II System)?

Stem Extension Line (USTAR II System) is manufactured by United Orthopedic Corporation.

What is the FDA product code for Stem Extension Line (USTAR II System)?

The FDA product code for Stem Extension Line (USTAR II System) is KRO.

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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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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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