ATTUNETM Rotating Platform (RP) Total Knee System, ATTUNETM Cementless Rotating Platform (RP) Total Knee System, ATTUNET
FDA premarket approval P830055/S325 · decided 2025-03-13
Approval details
- PMA number
- P830055
- Supplement
- S325
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ATTUNETM Rotating Platform (RP) Total Knee System, ATTUNETM Cementless Rotating Platform (RP) Total Knee System, ATTUNET
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Applicant
- Depuy, Inc.
- Date received
- 2024-06-28
- Decision date
- 2025-03-13
- Days to decision
- 258 days
- Decision code
- APPR
- Product code
- NJL
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- Approval for the addition of ATTUNETM Porous Medialized Dome and Anatomic Patella with AFFIXIUMTM 3DP Technology as compatible devices to the ATTUNETM Rotating Platform (RP) Total Knee System, ATTUNETM Cementless Rotating Platform (RP) Total Knee System, and ATTUNETM Revision Rotating Platform (RP) Total Knee System, and the following four associated manufacturing facilities:Paragon Medical, Inc.8 Matchett DrPierceton, Indiana 46562Role performed: Machining3D Systems, Inc.5381 South Alkire Circl
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| PINNACLE CONSTRAINED ACETABULAR LINERS (K043058) | Depuy, Inc. | 2005-03-14 |
| LPS UPPER EXTREMITY (K042664) | Depuy, Inc. | 2004-12-08 |
| LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY (K041085) | Depuy, Inc. | 2004-07-22 |
| LPS (K033959) | Depuy, Inc. | 2004-07-01 |
| DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062 (K040544) | Depuy, Inc. | 2004-05-28 |
| DELTA SHOULDER (K021478) | Depuy, Inc. | 2003-11-18 |
| DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS (K033329) | Depuy, Inc. | 2003-11-14 |
| DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS (K032151) | Depuy, Inc. | 2003-09-26 |