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Stem Extension Line (USTAR II System)

by United Orthopedic Corporation

510(k) K252303

Active European Union and United States

CE MDR CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K252303↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK252303 Date22 Aug 2025ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
KRO
Device class
Class II
Regulation
21 CFR Part 888.3510
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Stem Extension Line (USTAR II System) is a Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer, designed to extend or modify femoral stems in total knee arthroplasty. It provides structural reinforcement and alignment adjustments for constrained knee replacements, ensuring stability and durability in cemented fixation.

This device is intended for use in orthopedic surgical settings and is supplied as a reusable component within the USTAR II System. It is classified as a Class II medical device under FDA regulations (K-number: K252303) and adheres to FDA 510K, MDD, and MDR authorizations. Sterility and MRI safety are not specified in the provided data, but it is regulated under 21 CFR 888.3510 for knee prostheses.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Stem Extension Line (USTAR II System) used for in knee arthroplasty procedures?

    The Stem Extension Line (USTAR II System) is designed to extend or modify femoral stems in total knee arthroplasty. It provides structural reinforcement and helps adjust alignment for constrained knee replacements, ensuring stability and durability in cemented fixation scenarios.

  • Is the Stem Extension Line (USTAR II System) intended for single-use or reusable applications?

    The Stem Extension Line (USTAR II System) is supplied as a reusable component within the USTAR II System. This means it is intended for repeated use in orthopedic surgical settings, provided it adheres to proper sterilization and maintenance protocols.

  • What regulatory pathways has the Stem Extension Line (USTAR II System) followed for approval?

    The Stem Extension Line (USTAR II System) has been authorized through FDA 510K clearance, as well as compliance with the Medical Device Directive (MDD) and the Medical Device Regulation (MDR). It is classified as a Class II medical device under FDA regulations with the K-number K252303.

  • Are there specific sizes or models available for the Stem Extension Line (USTAR II System)?

    The provided data does not specify individual sizes or model variants for the Stem Extension Line (USTAR II System). However, it is listed under the product code KRO for Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer, indicating it is tailored for constrained knee replacements. For exact sizing details, consult the manufacturer’s catalog or technical documentation.

  • How is the Stem Extension Line (USTAR II System) regulated under FDA guidelines?

    The Stem Extension Line (USTAR II System) falls under the regulatory category of 21 CFR 888.3510 for knee prostheses. It was determined to be substantially equivalent (SESE) through a special clearance process by the FDA’s Orthopedic (OR) Advisory Committee, ensuring it meets the necessary safety and performance standards for constrained knee replacements.