LCS TOTAL KNEE SYSTEM
FDA premarket approval P830055/S077 · decided 2000-11-13
Approval details
- PMA number
- P830055
- Supplement
- S077
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- LCS TOTAL KNEE SYSTEM
- Generic name
- Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
- Applicant
- Depuy, Inc.
- Date received
- 2000-09-26
- Decision date
- 2000-11-13
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- NJL
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- APPROVAL FOR A CHANGE TO THE PACKAGE INSERT REGARDING THE INDICATED USES FOR THE P.F.C. SIGMA RP CURVED TIBIAL BEARINGS. THIS CHANGE IN INDICATION WOULD ALLOW THE P.F.C. SIGMA RP CURVED BEARINGS TO BE USED IN POSTERIOR CRUCIATE RETAINING PROCEDURES WHEN USED WITH THE P.F.C. SIGMA CRUCIATE RETAINING FEMORAL COMPONENT.
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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 |