DURALOC OPTION CERAMIC HIP SYSTEM
FDA premarket approval P040023/S008 · decided 2006-10-18
Approval details
- PMA number
- P040023
- Supplement
- S008
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- DURALOC OPTION CERAMIC HIP SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- DePuy Orthopaedics, Inc.
- Date received
- 2006-09-19
- Decision date
- 2006-10-18
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- APPROVAL FOR CHANGES TO THE WARNINGS AND PRECAUTIONS SECTION OF THE PACKAGE INSERT LABELING TO INCLUDE ADDITIONAL STATEMENTS THAT ADVISE THE SURGEON TO AVOID THE TAPER REGION AND SHELL FACE OF THE METAL ACETABULAR SHELL COMPONENT WHEN IMPACTING THE SHELL TO ADJUST THE POSITION OF THE COMPONENT.
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510(k) clearances by this applicant
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|---|---|---|
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| 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 |