Regulatory Decision Summary for I-Factor Flex FR
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
Product type:
Summary of Withdrawal or Refusal due to Non-response i-Factor Flex FR
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
Overview
What was the application for at the time of decision?
This medical device application is for a new Class IV licence. The i-Factor Flex FR device family consists of bone void filler strips formulated with P-15-coated bovine-derived anorganic bone mineral (ABM) (81.1%) that is suspended in hydrogel/polymeric binder (17.3%), mixed with 1.6 % silk fibers and lyophilized. The bovine-derived ABM particles within the matrix are radiopaque and sized between 250 and 425 microns. P-15 is a polypeptide consisting of fifteen amino acids, a portion of Type-I collagen that serves as a biomimetic attachment site for bone cells. The hydrogel prior to lyophilisation consists of 3.2 % carboxymethylcellulose, 14.5 % glycerin and 82.3% water. The silk component consists of purified short segment (9 ± 2 mm) of fibroin fibers from Bombyx mori silkworm cocoon containing less than 0.5% of sericin residual.
A similar device that contains the same ABM/P15 and the hydrogel/polymeric binder but does not contain the silk component is currently licensed on MDL #88907.
The subject device is provided sterile in lengths of 25 mm, 50 mm and 100 mm, in width of 25 mm and in height of 3.5 mm
The subject device is intended to fill bony voids or gaps in extremities and spine that are not intrinsic to the stability of the bony structure. Sufficient internal or external fixation is required.
Outcome of application
Withdrawn by the manufacturer following review and request for additional information, but prior to issuance of a decision by Health Canada