CERAMAX Ceramic Total Hip System
FDA premarket approval P070026/S108 · decided 2023-06-22
Approval details
- PMA number
- P070026
- Supplement
- S108
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CERAMAX Ceramic Total Hip System
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- DePuy Orthopaedics, Inc.
- Date received
- 2023-06-14
- Decision date
- 2023-06-22
- Days to decision
- 8 days
- Decision code
- OK30
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- Introduction of a new PROOFTEST SYSTEM to replace the current equipment asset used in the manufacturing process.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DePuy ATTUNE™ Knee System (K252887) | DePuy Orthopaedics, Inc. | 2026-05-22 |
| CUPTIMIZE™ Advanced (K231503) | DePuy Orthopaedics, Inc. | 2023-08-22 |
| DePuy Corail AMT Hip Prosthesis (K213839) | DePuy Orthopaedics, Inc. | 2022-01-06 |
| DELTA XTEND Reverse Shoulder System (K210167) | DePuy Orthopaedics, Inc. | 2021-02-19 |
| DePuy Corail AMT Hip Prosthesis (K203167) | DePuy Orthopaedics, Inc. | 2020-11-19 |
| ACTIS Duofix Hip Prosthesis (K202472) | DePuy Orthopaedics, Inc. | 2020-10-21 |
| DePuy ATTUNE™ Total Knee System (K201347) | DePuy Orthopaedics, Inc. | 2020-06-18 |
| TRUMATCH Personalized Solutions (K193540) | DePuy Orthopaedics, Inc. | 2020-06-16 |