LCS TOTAL KNEE SYSTEM
FDA premarket approval P830055/S133 · decided 2013-04-12
Approval details
- PMA number
- P830055
- Supplement
- S133
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LCS TOTAL KNEE SYSTEM
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Applicant
- Depuy, Inc.
- Date received
- 2013-03-14
- Decision date
- 2013-04-12
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- NJL
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- APPROVAL FOR AN ADDITIONAL INSPECTION STEP AFTER THE IN PROCESS CLEAN (IPC). THE INSPECTION WILL ENSURE THAT THERE WILL BE NO REMAINING POLISHING AGENTS LEFT ON THE ATTUNE CR AND ATTUNE PS FEMORAL COMPONENTS AFTER THE IPC STEP IS PERFORMED. THE ATTUNE CR AND ATTUNE PS FEMORAL COMPONENTS WERE PREVIOUSLY APPROVED AS COMPATIBLE COMPONENTS TO THE CLASS III ROTATING PLATFORM ATTUNE TIBIAL COMPONENTS.
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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 |