LCS TOTAL KNEE SYSTEM
FDA premarket approval P830055/S093 · decided 2005-12-12
Approval details
- PMA number
- P830055
- Supplement
- S093
- 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
- 2005-11-10
- Decision date
- 2005-12-12
- Days to decision
- 32 days
- Decision code
- APPR
- Product code
- NJL
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- APPROVAL FOR CHANGES IN QUALITY CONTROLS TO VARIOUS COMPONENTS OF THE LCS TOTAL KNEE SYSTEM. THE CHANGES INCLUDE MODIFICATIONS TO SEVERAL MANUFACTURING PROCESS SPECIFICATIONS (MPS) FOR GAMMA VACUUM FOIL (GVF) PACKAGED PRODUCTS: 1) TO ADD PHYSICAL SEPARATION BARRIERS TO THE SEALING MACHINE TO PREVENT ADJACENT FOIL POUCHES FROM OVERLAPPING DURING THE SEALING OPERATION, AND 2) TO REQUIRE A SECOND 100% INSPECTION OF THE SEAL INTEGRITY OF EACH PACKAGE PRIOR TO SHIPMENT.
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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 |