TheRay Collared and Collarless Femoral Stem
FDA 510(k) K241875 · Nextstep Arthropedix
510(k) numberK241875
Submission
- Device name
- TheRay Collared and Collarless Femoral Stem
- Applicant
- Nextstep Arthropedix
Akron, OH, US - Received
- June 28, 2024
- Decision date
- September 13, 2024
- 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 |
| K242315 | Resolve Modular Revision Hip StemMEH · Traditional | United Orthopedic Corporation | 05/01/2025SE |
| 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 |
| 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 |
|---|---|---|
| K242410 | NextStep Arthropedix Total Knee SystemJWH · Traditional | 05/08/2025SE |
Questions and answers
When was TheRay Collared and Collarless Femoral Stem cleared by the FDA?
TheRay Collared and Collarless Femoral Stem (K241875) received a 510(k) decision of Substantially Equivalent on September 13, 2024, 77 days after the submission was received.
What is the product code of K241875?
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.