DEPUY PINNACLE COMPLETE ACETABULAR HIP SYSTEM
FDA premarket approval P090002/S002 · decided 2012-04-17
Approval details
- PMA number
- P090002
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DEPUY PINNACLE COMPLETE ACETABULAR HIP SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, ceramic-on-metal articulation
- Applicant
- DePuy Orthopaedics, Inc.
- Date received
- 2012-01-19
- Decision date
- 2012-04-17
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- OVO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- APPROVAL FOR THE ADDITION OF THE TRILOCK BPS (BONE PRESERVING HIP STEM) TO THE LIST OF COMPATIBLE FEMORAL STEM COMPONENTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DEPUY PINNACLE COMPLETE ACETABULAR HIP SYSTEM AND IS INDICATED AS A SINGLE USE DEVICE INTENDED FOR UNCEMENTED FIXATION. THE DEVICE IS INTENDED AS A PRIMARY JOINT REPLACEMENT PROSTHESIS IN TOTAL HIP ARTHROPLASTY FOR SKELETALLY MATURE PATIENTS SUFFERING AT LEAST MODERATE PAIN IN THE HIP JOINT FROM NON-INFLAMMATORY
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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 |