DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR Conditional
FDA 510(k) clearance K231873 · decided 2024-01-19
Clearance details
- K-number
- K231873
- Device name
- DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR Conditional
- Applicant
- Depuy Ireland UC
- Decision
- Substantially Equivalent
- Date received
- 2023-06-26
- Decision date
- 2024-01-19
- Days to decision
- 207 days
- Clearance type
- Traditional
- Product code
- MEH
- Device class
- 2
- Regulation number
- 888.3353
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Ringaskiddy, IE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Allure Hip Stem and Intramedullary Plugs (K250375) | Waldemar Link GmbH & Co. KG | 2025-11-05 |
| Mfinity Femoral System (K251166) | Medacta International S.A. | 2025-06-13 |
| Trivicta® Hip Stem (K251052) | Ortho Development Corp. | 2025-05-22 |
| Resolve Modular Revision Hip Stem (K242315) | United Orthopedic Corporation | 2025-05-01 |
| Alteon® HA Femoral Stems (K243839) | Exactech, Inc. | 2025-03-10 |
| World Liner (K243162) | Signature Orthopaedics Pty, Ltd. | 2024-11-25 |
| Icona Hip Stem (K241472) | Corin U.S.A. Limited | 2024-10-03 |
| TheRay Collared and Collarless Femoral Stem (K241875) | Nextstep Arthropedix | 2024-09-13 |
| Logical Liner; World Liner; World Knee Patella (K241690) | Signature Orthopaedics Pty, Ltd. | 2024-08-01 |
| Trivicta™ Hip Stem (K233758) | Ortho Development Corp. | 2024-03-08 |
| ACTERA™ hip system (K231178) | Conformis, Inc. | 2023-05-23 |
| SignaSure Dual Mobility System (K220495) | Signature Orthopaedics Pty, Ltd. | 2023-01-13 |
Recalls involving this device
No recalls on record reference this clearance.