Resolve Modular Revision Hip Stem
FDA 510(k) K242315 · United Orthopedic Corporation
510(k) numberK242315
Submission
- Device name
- Resolve Modular Revision Hip Stem
- Applicant
- United Orthopedic Corporation
Hsinchu City, TW - Received
- August 5, 2024
- Decision date
- May 1, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MEH – Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3353
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MEH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261576 | Icona Hip StemMEH · Traditional | Corin, Ltd. | 08/10/2026SE |
| K250375 | Allure Hip Stem and Intramedullary PlugsMEH · Traditional | Waldemar Link GmbH & Co. KG | 11/05/2025SE |
| K251166 | Mfinity Femoral SystemMEH · Traditional | Medacta International S.A. | 06/13/2025SE |
| K251052 | Trivicta® Hip StemMEH · Traditional | Ortho Development Corp. | 05/22/2025SE |
| K243839 | Alteon® HA Femoral StemsMEH · Traditional | Exactech, Inc. | 03/10/2025SE |
| K243162 | World LinerMEH · Special | Signature Orthopaedics Pty, Ltd. | 11/25/2024SE |
| K241472 | Icona Hip StemMEH · Traditional | Corin U.S.A. Limited | 10/03/2024SE |
| K241875 | TheRay Collared and Collarless Femoral StemMEH · Traditional | Nextstep Arthropedix | 09/13/2024SE |
| K241690 | Logical Liner; World Liner; World Knee PatellaMEH · Special | Signature Orthopaedics Pty, Ltd. | 08/01/2024SE |
| K233758 | Trivicta Hip StemMEH · Traditional | Ortho Development Corp. | 03/08/2024SE |
More from Ortho Development Corp.
| 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 |
| K252303 | Stem Extension Line (USTAR II System)KRO · Special | 08/22/2025SE |
| K243656 | U2 Total Knee System PF+ Patella; USTAR II System PF+ PatellaMBH · Traditional | 07/31/2025SE |
| 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 Resolve Modular Revision Hip Stem cleared by the FDA?
Resolve Modular Revision Hip Stem (K242315) received a 510(k) decision of Substantially Equivalent on May 1, 2025, 269 days after the submission was received.
What is the product code of K242315?
The FDA product code is MEH – Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate, a Class II (moderate risk) device regulated under 21 CFR 888.3353.