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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namesemi-constrained metal/polymer finger joint prosthesis
Generic Namesemi-constrained metal/polymer finger joint prosthesis
Encore Medical L/P. d/b/a DJO Surgical
9800 metric boulevard
austin, TX 78758
HDE NumberH010001
Date Received05/16/2001
Decision Date08/28/2001
Product Code
MPK[ Registered Establishments with MPK ]
Docket Number 01M-0392
Advisory Committee Orthopedic
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
The avanta metacarpophalangeal (mcp) joint implant finger prosthesis is indicated for use in arthroplasty of the mcp joint when either the: (1) patient is in need of a revision of failed mcp prothesis(es); or (2) patient expects to place his/her hands under loading situations which preclude the use of an alternative implant in the painful osteo-arthritic and post traumatic arthritic mcp joint.
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006