PMA P910016S009
- Device
- Lcs(r)total Knee System
- Applicant
- DEPUY, INC.
- PMA number
- P910016
- Supplement
- S009
- Decision date
- 1998-01-15
Current openFDA PMA Record
- Device
- LCS(R)TOTAL KNEE SYSTEM
- Applicant
- Depuy, Inc.
- PMA number
- P910016
- Supplement
- S009
- Product code
- MBD
- Generic name
- PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
- Decision date
- 1998-01-15
- Decision code
- APPR
- Date received
- 1997-11-25
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order 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 osteoarthritis or post-traumatic arthritis.