Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: LT-CAGE LUMBAR TAPERED FUSION DEVICE
• Generic Name: Intervertebral fusion device with bone graft, lumbar
• Regulation Number: 888.3080
• Applicant: SOFAMOR DANEK; 1800 Pyramid Place; Memphis, TN 38132
• PMA Number: P970015
• Supplement Number: S029
• Date Received: 09/22/2004
• Decision Date: 07/22/2005
• Reclassified Date: 07/12/2007
• Product Code: MAX
• Advisory Committee: Orthopedic
• Supplement Type: Real-Time Process
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
APPROVAL FOR THE ADDITION OF THE 14MM X 26MM CAGE TITANIUM LT-CAGE LUMBAR TAPERED FUSION DEVICE. THE DEVICE REMAINS INDICATED FOR SPINAL FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE LEVEL FROM L2-S1. DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY PATIENT HISTORY AND RADIOGRAPHIC STUDIES. THESE DDD PATIENTS MAY ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS OR RETROLISTHESIS AT THE INVOLVED LEVEL. LT-CAGE DEVICES ARE TO BE USED WITH AUTOGENOUS BONE GRAFT AND IMPLANTED VIA A LAPAROSCOPIC OR AN OPEN ANTERIOR APPROACH. PATIENTS RECEIVING THE LT-CAGE LUMBAR TAPERED FUSION DEVICE SHOULD HAVE HAD AT LEAST SIX MONTHS OF NONOPERATIVE TREATMENT PRIOR TO TREATMENT WITH THE LT-CAGE DEVICE.