CFR / 
Title 21
 / Part 888
 / 
Sec. 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.
(a) Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.