LCS(R)TOTAL KNEE SYSTEM
FDA premarket approval P910016/S009 · decided 1998-01-15
Approval details
- PMA number
- P910016
- Supplement
- S009
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- LCS(R)TOTAL KNEE SYSTEM
- Generic name
- PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
- Applicant
- Depuy, Inc.
- Date received
- 1997-11-25
- Decision date
- 1998-01-15
- Days to decision
- 51 days
- Decision code
- APPR
- Product code
- MBD
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- Approval for a change to the name of the Unicompartmental Configuration of the new jersey LCS(R) Total Knee System. This device will now be marketed under the trade name Unicompartmental Configuraiton ofthe LCS(R) Total Knee System and is indicated for uncemented use in patients over 60 years old undergoing unicompartmental knee surgery for rehabilitating knees when only one condyle has been damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of o
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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 |