M-Cor Hip Replacement System
FDA 510(k) K053417 · Portland Orthopaedics Pty. , Ltd.
510(k) numberK053417
Submission
- Device name
- M-Cor Hip Replacement System
- Applicant
- Portland Orthopaedics Pty. , Ltd.
Stillwater, MN, US - Received
- December 8, 2005
- Decision date
- July 20, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LPH – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3358
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code LPH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253630 | Mpact 3D Metal FoamLPH · Traditional | Medacta International S.A. | 08/28/2026SE |
| K254043 | TRIVANCE Hip StemLPH · Traditional | Globus Medical, Inc. | 08/04/2026SE |
| K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…LPH · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 07/10/2026SE |
| K243192 | iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…LPH · Traditional | Nextstep Arthopedix, LLC | 06/05/2026SE |
| K251270 | Taperloc® Complete Hip StemLPH · Traditional | Biomet, Inc. | 05/19/2026SE |
| K252623 | G7® Revision Acetabular SystemLPH · Traditional | Zimmer, Inc. | 02/04/2026SE |
| K251043 | Mpact 3D Metal Implants Extension DMLS TechnologyLPH · Traditional | Medacta International S.A. | 01/28/2026SE |
| K252067 | Velora Acetabular SystemLPH · Traditional | Restor3D, Inc. | 12/05/2025SE |
| K252846 | TaperSet Hip SystemLPH · Special | Shalby Advanced Technologies, Inc. Dba Consensus… | 11/20/2025SE |
| K251833 | EMPOWR Acetabular® Liner ExtensionLPH · Traditional | Encore Medical L.P. | 11/12/2025SE |
More from Encore Medical L.P.
| 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 |
| K051844 | Equator Plus Acetabular Cup SystemMAY · Traditional | 10/07/2005SE |
| K032641 | Modification to: the Margron Hip Replacement SystemMEH · Special | 01/20/2004SE |
| K992815 | The Margron Hip Replacement SystemMEH · Traditional | 02/07/2000SE |
Questions and answers
When was M-Cor Hip Replacement System cleared by the FDA?
M-Cor Hip Replacement System (K053417) received a 510(k) decision of Substantially Equivalent on July 20, 2006, 224 days after the submission was received.
What is the product code of K053417?
The FDA product code is LPH – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3358.