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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.
 
DeviceOxford Partial Knee System
Generic NameProsthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
ApplicantBiomet Manufacturing Corp
56 E. Bell Dr.,
P.O. Box 587
Warsaw, IN 46581
PMA NumberP010014
Supplement NumberS109
Date Received05/06/2025
Decision Date08/07/2025
Product Code NRA 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for new Cemented and Cementless versions of the Oxford Partial Knee System Tibial Tray component (referred to as the Oxford Anatomic Tibial components).
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