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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceLT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE
Generic NameIntervertebral fusion device with bone graft, lumbar
Regulation Number888.3080
ApplicantSOFAMOR DANEK
1800 Pyramid Place
Memphis, TN 38132
PMA NumberP970015
Supplement NumberS022
Date Received10/30/2002
Decision Date09/10/2003
Reclassified Date 07/12/2007
Product Code MAX 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE LT-CAGE PEEK LUMBER TAPERED FUSION DEVICE, WHICH IS MANUFACTURED FROM POLYETHERETHERKE-TONE, WITH THE TRADE NAME OF PEEK-OPTIMA LT1. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE AND IS INDICATED FOR SPINAL FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WITH DEGERNERATIVE 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 ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS OR RETROLISTHESIS AT THE INVOLVED LEVEL. LT-CAGE PEEK IMPLANTS ARE TO BE USED WITH AUTOGENOUS BONE GRAFT AND IMPLANTED VIA A LAPAROSCOPIC OR AN OPEN ANTERIOR APPROACH. PATIENTS RECEIVING THE LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE SHOULD HAVE AT LEAST SIX MONTHS OF NON-OPERATIVE TREATMENT PRIOR TREATMENT WITH THE LT-CAGE PEEK DEVICE.
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