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: INTER FIX RP THREADED FUSION DEVICE-REDUCED PROFILE
• 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: S017
• Date Received: 09/28/2000
• Decision Date: 12/13/2000
• Reclassified Date: 07/12/2007
• Product Code: MAX
• Advisory Committee: Orthopedic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
APPROVAL FOR THE INTERFIX(TM) RP THREADED FUSION DEVICE TO BE ALSO KNOWN AS THE INTERFIX(TM) RP THREADED FUSION DEVICE - REDUCED PROFILE. THE DEVICE WILL NOW BE MARKETED UNDER BOTH TRADE NAMES AND WILL REMAIN INDICATED FOR USE WITH AUTOGENOUS BONE BRAFT IN PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE LEVEL FROM L2-S1. THESE DDD PATIENTS MAY ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS OR RETROLISTHESIS AT THE INVOLVED LEVEL. THE DEVICE IS TO BE IMPLANTED VIA AN OPEN ANTERIOR APPROACH. DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY HISTORY AND RADIOGRAPHIC STUDIES. THESE PATIENTS SHOULD BE SKELETALLY MATURE AND HAVE HAD SIX MONTHS OF NON-OPERATIVE TREATMENT.