# MRA · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/productcode/MRA

## Overview

- **Product Code:** MRA
- **Device Name:** Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **Implant:** yes

## Recent Cleared Devices (13 of 13)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P150030](/device/P150030.md) | R3 DELTA CERAMIC HIP SYSTEM | Smith & Nephew, Inc. | Oct 17, 2016 | APWD |
| [P070026](/device/P070026.md) | CERAMAX CERAMIC HIP SYSTEM | DePuy Orthopaedics, Inc. | Dec 23, 2010 | APPR |
| [P050039](/device/P050039.md) | NOVATION CERAMIC ARTICULATION HIP SYSTEM | Exactech, Inc. | Jul 5, 2007 | APWD |
| [P040048](/device/P040048.md) | TRILOGY AB ACETABULAR SYSTEM | Zimmer, Inc. | Jun 28, 2006 | APWD |
| [P040051](/device/P040051.md) | STELKAST SURPASS  ACETABULAR SYSTEM | Stelkast Company | May 12, 2006 | APWD |
| [P050009](/device/P050009.md) | C2 A-TAPER ACETABULAR SYSTEM | Biomet, Inc. | Dec 16, 2005 | APWD |
| [P040023](/device/P040023.md) | DURALOC OPTION CERAMIC HIP SYSTEM | DePuy Orthopaedics, Inc. | May 3, 2005 | APWD |
| [P030022](/device/P030022.md) | REFLECTION CERAMIC ACETABULAR SYSTEM | Smith & Nephew, Inc. | Dec 17, 2004 | APWD |
| [N980003](/device/N980003.md) | KERAMOS CERAMIC/CERAMIC TOTAL HIP SYSTEM | Djo Surgical | Nov 26, 2003 | APWD |
| [P030027](/device/P030027.md) | CERAMIC TRANSCEND HIP ARTICULATION | Microport Orthopedics, Inc. | Jul 7, 2003 | APPR |
| [P010001](/device/P010001.md) | CERAMIC TRANSCEND HIP ARTICULATION SYSTEM | Ceramtec GmbH | Feb 3, 2003 | APPR |
| [P000013](/device/P000013.md) | TRIDENT SYSTEM | Howmedica Osteonics Corp. | Feb 3, 2003 | APPR |
| [P810048](/device/P810048.md) | OSTEO CERAMIC HIP | Smith & Nephew, Inc. | Nov 5, 1982 | APWD |

## Top Applicants

- Smith & Nephew, Inc. — 3 clearances
- DePuy Orthopaedics, Inc. — 2 clearances
- Biomet, Inc. — 1 clearance
- Ceramtec GmbH — 1 clearance
- Djo Surgical — 1 clearance

---

**Source:** [https://fda.innolitics.com/productcode/MRA](https://fda.innolitics.com/productcode/MRA)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com