Stem Extension Line (USTAR II System)
FDA 510(k) K252303 · United Orthopedic Corporation
510(k) numberK252303
Submission
- Device name
- Stem Extension Line (USTAR II System)
- Applicant
- United Orthopedic Corporation
Kaohsiung, TW - Received
- July 24, 2025
- Decision date
- August 22, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KRO – Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3510
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KRO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261898 | Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemKRO · Traditional | Howmedica Osteonics Corp. dba Stryker Orthopaedics | 08/06/2026SE |
| K252898 | Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella…KRO · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 12/15/2025SE |
| K251665 | Triathlon® Hinge Knee SystemKRO · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 07/25/2025SE |
| K242871 | ATTUNE Revision Hinge KneeKRO · Traditional | Depuy Ireland UC | 11/21/2024SE |
| K240043 | EVOLUTION® Hinge Knee System;GUARDIAN limb Salvage System;DCW Modular Distal Femoral…KRO · Traditional | Microport Orthopedics, Inc. | 04/01/2024SE |
| K233980 | ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System…KRO · Traditional | Depuy Ireland UC | 03/21/2024SE |
| K230563 | EVOLUTION® Hinge Knee SystemKRO · Traditional | Microport Orthopedics, Inc. | 09/27/2023SE |
| K230416 | Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®KRO · Traditional | Stryker | 05/19/2023SE |
| K223069 | Modular Rotating Hinge Knee Systems and Compatible ComponentsKRO · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 04/21/2023SE |
| K223528 | Triathlon® Hinge Knee SystemKRO · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 01/20/2023SE |
More from Howmedica Osteonics Corp., Dba Stryker Orthopaedics
| 510(k) | Device | Decision |
|---|---|---|
| K253948 | Momentum Acetabular Cup SystemLZO · Traditional | 09/02/2026SE |
| K252725 | Stem Extension Line (U2 Total Knee SystemPSA Type)JWH · Special | 09/25/2025SE |
| K243656 | U2 Total Knee System PF+ Patella; USTAR II System PF+ PatellaMBH · Traditional | 07/31/2025SE |
| K242315 | Resolve Modular Revision Hip StemMEH · Traditional | 05/01/2025SE |
| K243466 | Conformity Stem Extension Line, #0LZO · Traditional | 01/06/2025SE |
| K243024 | Cellbrick Knee SpacerJWH · Traditional | 12/20/2024SE |
| K242249 | Conformity Stem Extension LineLZO · Special | 08/30/2024SE |
| K221705 | U2 Total Knee System-PF+MBH · Traditional | 02/28/2023SE |
| K221149 | U-Motion II Acetabular System-Extension lineLZO · Traditional | 01/05/2023SE |
| K221675 | United U2 femoral head, 22mm delta ceramic headLPH · Special | 11/04/2022SE |
Questions and answers
When was Stem Extension Line (USTAR II System) cleared by the FDA?
Stem Extension Line (USTAR II System) (K252303) received a 510(k) decision of Substantially Equivalent on August 22, 2025, 29 days after the submission was received.
What is the product code of K252303?
The FDA product code is KRO – Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3510.