LCS TOTAL KNEE SYSTEM
FDA premarket approval P830055/S090 · decided 2005-09-26
Approval details
- PMA number
- P830055
- Supplement
- S090
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LCS TOTAL KNEE SYSTEM
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Applicant
- Depuy, Inc.
- Date received
- 2005-07-18
- Decision date
- 2005-09-26
- Days to decision
- 70 days
- Decision code
- APPR
- Product code
- NJL
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- APPROVAL TO: CHANGE THE NAME OF THE LCS COMPLETE M1 PS FEMORAL COMPONENT TO THE LCS COMPLETE RPS FEMORAL COMPONENT, ADD NEW SIZES ALONG WITH SOME MINOR DESIGN CHANGES TO THE RPS FEMORAL COMPONENTS, CHANGE THE NAME OF THE LCS COMPLETE M1 PS TIBIAL BEARING COMPONENT TO THE LCS COMPLETE RPS TIBIAL BEARING COMPONENT, ADD NEW BEARING THICKNESSES TO THE RPS TIBIAL BEARING COMPONENTS, AND MAKE DIMENSIONAL CHANGES TO THE TIBIAL REINFORCEMENT PIN USED WITH THE RPS TIBIAL BEARINGS; CHANGE THE CAM AND SPIN
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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 |