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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device.
 
Trade NameVERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR)
Classification Nameprosthesis, rib replacement
Generic Nameprosthesis, rib replacement
Regulation Number888.3070
Applicant
SYNTHES SPINE
325 paramount drive
raynham, MA 02767
HDE NumberH030009
Supplement NumberS004
Date Received03/15/2007
Decision Date05/25/2007
Product Code
MDI[ Registered Establishments with MDI ]
Advisory Committee Orthopedic
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for minor component modifications and related changes to the labeling for the vertical expandable prosthetic titanium rib (veptr). The device, asmodified, will be marketed under the trade name vertical expandable prosthetic titanium rib ii (veptr ii) and is indicated for the treatment of thoracic insufficiency syndrome (tis) in skeletally immature patients. Tis is defined as the inability of the thorax to support normal respiration or lung growth. For the purpose of identifying potential tis patients, the categories in which tis patients fall are as follows: 1) flail chest syndrome;2) constrictive chest wall §yndrome, including a) rib fusion and scoliosis;3) hypoplastic thorax syndrome, including a) jeune's syndrome b) achondroplasia c) jarcho-levin syndrome d) ellis van creveld syndome4) progressive scoliosis of congenital or neurogenic origin without rib anomaly.
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