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. |
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Device | LT-CAGE PEEK 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 | S022 |
Date Received | 10/30/2002 |
Decision Date | 09/10/2003 |
Reclassified Date
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07/12/2007 |
Product Code |
MAX |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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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