• 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 | Inspections

New Search Back to Search Results
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameprosthesis, hip, semi-constrained, metal/metal, resurfacing
Generic Nametotal hip resurfacing prosthesis, metal-on-metal
PMA NumberP040033
Supplement NumberS001
Date Received08/23/2006
Decision Date10/13/2006
Product Code
NXT[ Registered Establishments with NXT ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for: 1) addition of intermediate sized femoral head components to the bhr system (40mm, 44mm, 48mm, 52mm and 56mm); 2) addition of acetabular cups that mate with the intermediate sized femoral head components (standard, dysplasia and bridging); and 3) revisions to the bhr labeling to reflect the additional intermediate sized components.