LCS TOTAL KNEE SYSTEM
FDA premarket approval P830055/S067 · decided 1999-11-22
Approval details
- PMA number
- P830055
- Supplement
- S067
- 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
- 1999-10-18
- Decision date
- 1999-11-22
- Days to decision
- 35 days
- Decision code
- APPR
- Product code
- NJL
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- Approval for several sizes of newly developed trochlear groove implants to be used in conjunction with currently marketed patellar componenets of the LCS Total Knee System for the purpose of resurfacing the patellofemoral joint. This device is indicated for patients with isolated patellofemoral osteoarthritis, a history of patellar dislocation or patellar fracture, or a failed previous surgery where pain, deformity or dysfunction persist. The trochlear implants are intended for cemented use only
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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 |