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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™ Cementless Partial Knee System
Generic NameProsthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
ApplicantBIOMET MANUFACTURING CORP.
56 EAST BELL DRIVE
P.O. BOX 587
WARSAW, IN 46581-0587
PMA NumberP010014
Supplement NumberS105
Date Received06/05/2023
Decision Date11/22/2024
Product Code NRA 
Advisory Committee Orthopedic
Clinical TrialsNCT01473134
Supplement TypePanel Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
The Oxford Cementless Partial Knee System is indicated for use in unilateral knee procedures with osteoarthritis or avascular necrosis limited to the medial compartment of the knee. It is intended to be implanted without the application of bone cement for patients whose clinical condition would benefit from a shorter surgical time compared to the cemented implant.
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