d e p a r t m e n t o f h e a l t h a n d h u m a n s e r v i c e s（因为这是一个值得一提的人，所以这世上只有一个机会。）.docVIP

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d e p a r t m e n t o f h e a l t h a n d h u m a n s e r v i c e s（因为这是一个值得一提的人，所以这世上只有一个机会。）.doc

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d e p a r t m e n t o f h e a l t h a n d h u m a n s e r v i c e s（因为这是一个值得一提的人，所以这世上只有一个机会。）

DEPARTMENT OF HEALTH AND HUMAN SERVICES PMA MEMORANDUM Division of General, Restorative and Neurological Devices Orthopedic Devices Branch, HFZ-410 (301) 594-2036 Food and Drug Administration Office of Device Evaluation Center for Devices and Radiological Health 9200 Corporate Boulevard Rockville, MD 20850 Charité? Artificial Disc DePuy Spine 325 Paramount Drive Raynham, MA 02767-0350 (508) 880-8100 CLINICAL REVIEW SUMMARY The subject device is the Charité? Artificial Disc, consisting of two CoCrMo alloy endplates and an UHMWPE core, indicated for spinal arthroplasty in patients with single-level lumbar degenerative disc disease (DDD) from L4 to S1. The sponsor conducted a non-inferiority randomized, prospective clinical trial comparing the clinical results of treatment with the subject device and anterior interbody fusion using the BAK fusion cage. The study demonstrated that the Charité? Artificial Disc is safe and effective in the treatment of lumbar DDD compared to anterior interbody fusion with the BAK cage. REVIEW The subject of this review is P040006, the clinical module for M020026/M003, dated 2/13/04 and received 2/13/04. Regulatory History The Modular Shell was approved 3/4/03. The first module, M001, was filed on 3/12/03. The second module, M002, was filed 4/17/03. CLINICAL INFORMATION The subject device (as well as previous design versions) has been commercially available in other countries since 1987. The sponsor estimates that over 7,000 patients worldwide have received a Charité Artificial Disc replacement. The Waldemar Link Company in Hamburg, Germany is manufacturer of the device. CLINICAL TRIALS INVESTIGATIONAL PLAN The sponsor states that five versions of the protocol were utilized in this study. The sponsor provided a summary of the changes in Volume 14, pp.1-8. The investigational plan is summarized below with the protocol changes noted in the ap