Modification to: the Margron Hip Replacement System
FDA 510(k) K032641 · Portland Orthopaedics Pty. , Ltd.
510(k) numberK032641
Submission
- Device name
- Modification to: the Margron Hip Replacement System
- Applicant
- Portland Orthopaedics Pty. , Ltd.
Matraville Nsw, AU - Received
- August 27, 2003
- Decision date
- January 20, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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|---|---|---|---|
| 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 |
| 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 |
More from Signature Orthopaedics Pty, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K063278 | Portland Cobalt Chrome Femoral HeadJDI · Traditional | 01/12/2007SE |
| K061564 | Portland Ceramic (Biolox-Forte) Femoral HeadLZO · Traditional | 09/01/2006SE |
| K053417 | M-Cor Hip Replacement SystemLPH · Traditional | 07/20/2006SE |
| K051844 | Equator Plus Acetabular Cup SystemMAY · Traditional | 10/07/2005SE |
| K992815 | The Margron Hip Replacement SystemMEH · Traditional | 02/07/2000SE |
Questions and answers
When was Modification to: the Margron Hip Replacement System cleared by the FDA?
Modification to: the Margron Hip Replacement System (K032641) received a 510(k) decision of Substantially Equivalent on January 20, 2004, 146 days after the submission was received.
What is the product code of K032641?
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.