Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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 NumberS055
Date Received08/05/2016
Decision Date09/01/2016
Product Code NRA 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition of a radiographic assessment decision aid to supplement the patient selection criteria provided in the approved surgical technique for the Oxford Partial Knee System.
-
-