ATTUNE Revision Knee System
FDA premarket approval P830055/S360 · decided 2026-08-05
Approval details
- PMA number
- P830055
- Supplement
- S360
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ATTUNE Revision Knee System
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Applicant
- Depuy, Inc.
- Date received
- 2026-02-06
- Decision date
- 2026-08-05
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- NJL
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- approval for a manufacturing site located at DePuy International Ltd., Leeds, LS11 8DT, United Kingdom, as an additional manufacturing site for the ATTUNE Revision Tibial Sleeve products, and a manufacturing site located at Synergy Health Sterilization UK Limited, Reading, Berkshire, RG30 4EA, United Kingdom, as an additional sterilization facility for the ATTUNE Revision Tibial Sleeve products.
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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 |