Product code MRA
- Device name
- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P070026S125 | Ceramax® Ceramic Hip System | DePuy Orthopaedics, Inc. | 2026-04-29 |
| P070026S124 | Ceramax Ceramic Hip System | DePuy Orthopaedics, Inc. | 2026-04-10 |
| P070026S118 | Ceramax® Ceramic Total Hip System | DePuy Orthopaedics, Inc. | 2026-01-08 |
| P070026S123 | Ceramax Ceramic Hip System | DePuy Orthopaedics, Inc. | 2025-12-09 |
| P000013S027 | Trident Alumina Insert (625-0T-XXX); Osteonics® ABC/Trident® System | Howmedica Osteonics Corp. | 2025-09-17 |
| P070026S121 | CERAMAX CERAMIC HIP SYSTEM | DePuy Orthopaedics, Inc. | 2025-08-05 |
| P070026S122 | CERAMAX CERAMIC HIP SYSTEM | DePuy Orthopaedics, Inc. | 2025-08-01 |
| P070026S120 | CERAMAX® ceramic total hip system | DePuy Orthopaedics, Inc. | 2025-06-24 |
| P010001S031 | Transcend® Hip Articulation System | Ceramtec GmbH | 2025-06-20 |
| P010001S030 | Ceramic TRANSCEND® Hip Articulation System | Ceramtec GmbH | 2025-06-05 |
| P000013S026 | Trident Acetabular System: Trident Alumina Inserts | Howmedica Osteonics Corp. | 2025-05-23 |
| P010001S029 | Ceramic TRANSCEND® Hip Articulation System | Ceramtec GmbH | 2025-04-23 |
| P150030S049 | R3™ Delta Ceramic Acetabular System | Smith & Nephew, Inc. | 2025-04-17 |
| P070026S119 | CERAMAX CERAMIC HIP SYSTEM | DePuy Orthopaedics, Inc. | 2025-04-04 |
| P070026S114 | DePuy Ceramax Ceramic Total Hip System | DePuy Orthopaedics, Inc. | 2025-03-19 |
| P150030S048 | R3 DELTA CERAMIC HIP SYSTEM | Smith & Nephew, Inc. | 2025-03-03 |
| P150030S045 | R3 Delta Ceramic Hip System | Smith & Nephew, Inc. | 2025-02-28 |
| P150030S047 | R3™ Delta Ceramic Acetabular System | Smith & Nephew, Inc. | 2025-02-21 |
| P070026S117 | Ceramax Ceramic Hip System | DePuy Orthopaedics, Inc. | 2025-02-21 |
| P070026S116 | Ceramax® Ceramic Total Hip System | DePuy Orthopaedics, Inc. | 2025-02-11 |
| P150030S046 | R3™ Delta Ceramic Acetabular System | Smith & Nephew, Inc. | 2025-01-16 |
| P070026S115 | CERAMAX Ceramic Hip System | DePuy Orthopaedics, Inc. | 2024-11-08 |
| P070026S113 | CERAMAX Ceramic Total Hip System | DePuy Orthopaedics, Inc. | 2024-10-23 |
| P010001S028 | Transcend® Hip Articulation System | Ceramtec GmbH | 2024-10-16 |
| P150030S043 | R3TM delta Ceramic Acetabular System | Smith & Nephew, Inc. | 2024-09-13 |
| P150030S044 | R3TM DELTA CERAMIC ACETABULAR SYSTEM | Smith & Nephew, Inc. | 2024-09-10 |
| P150030S042 | R3 Delta Ceramic Hip System, and POLARSTEM PMA Auxiliary Products | Smith & Nephew, Inc. | 2024-08-30 |
| P070026S112 | CERAMAX® Ceramic Total Hip System | DePuy Orthopaedics, Inc. | 2024-08-06 |
| P150030S041 | R3 DELTA Ceramic Hip System | Smith & Nephew, Inc. | 2024-07-23 |
| P150030S040 | R3 DELTA CERAMIC ACETABULAR SYSTEM | Smith & Nephew, Inc. | 2024-06-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| M684260000071 | Lineage | Microport Orthopedics Inc. | 2016-08-31 |
| M684365800561 | Lineage | Microport Orthopedics Inc. | 2016-08-31 |
| M684365800541 | Lineage | Microport Orthopedics Inc. | 2016-08-31 |
| M684365800521 | Lineage | Microport Orthopedics Inc. | 2016-08-31 |
| M684365800501 | Lineage | Microport Orthopedics Inc. | 2016-08-31 |
| M684365800481 | Lineage | Microport Orthopedics Inc. | 2016-08-31 |
| M684365800461 | Lineage | Microport Orthopedics Inc. | 2016-08-31 |
| M684260000151 | Lineage | Microport Orthopedics Inc. | 2016-08-31 |
| M684260000141 | Lineage | Microport Orthopedics Inc. | 2016-08-31 |
| M684260000131 | Lineage | Microport Orthopedics Inc. | 2016-08-31 |
| M684260000121 | Lineage | Microport Orthopedics Inc. | 2016-08-31 |
| M684260000111 | Lineage | Microport Orthopedics Inc. | 2016-08-31 |
| M684260000101 | Lineage | Microport Orthopedics Inc. | 2016-08-31 |
| M684260000091 | Lineage | Microport Orthopedics Inc. | 2016-08-31 |
| M684260000081 | Lineage | Microport Orthopedics Inc. | 2016-08-31 |
| M684260000061 | Lineage | Microport Orthopedics Inc. | 2016-08-31 |
| M684260000051 | Lineage | Microport Orthopedics Inc. | 2016-08-31 |
| M684260000041 | Lineage | Microport Orthopedics Inc. | 2016-08-31 |
| 10603295033608 | BIOLOX DELTA | DEPUY ORTHOPAEDICS, INC. | 2015-09-24 |
| 10603295033455 | BIOLOX DELTA | DEPUY ORTHOPAEDICS, INC. | 2015-09-24 |
| 10603295033448 | BIOLOX DELTA | DEPUY ORTHOPAEDICS, INC. | 2015-09-24 |
| 10603295033431 | BIOLOX DELTA | DEPUY ORTHOPAEDICS, INC. | 2015-09-24 |
| 10603295033424 | BIOLOX DELTA | DEPUY ORTHOPAEDICS, INC. | 2015-09-24 |
| 10603295033417 | BIOLOX DELTA | DEPUY ORTHOPAEDICS, INC. | 2015-09-24 |
| 10603295033400 | BIOLOX DELTA | DEPUY ORTHOPAEDICS, INC. | 2015-09-24 |
| 10603295009726 | PINNACLE | DEPUY ORTHOPAEDICS, INC. | 2015-09-24 |
| 10603295009719 | PINNACLE | DEPUY ORTHOPAEDICS, INC. | 2015-09-24 |
| 10603295009702 | PINNACLE | DEPUY ORTHOPAEDICS, INC. | 2015-09-24 |
| 10603295008613 | PINNACLE POROCOAT | DEPUY ORTHOPAEDICS, INC. | 2015-03-24 |
| 10603295008651 | PINNACLE POROCOAT | DEPUY ORTHOPAEDICS, INC. | 2015-03-24 |