21 C.F.R. § 888.3720
Toe joint polymer constrained prosthesis.
Cite as 21 C.F.R. § 888.3720 (2026)
(a)
Identification.
A toe joint polymer constrained prosthesis is a device made of silicone elastomer or polyester reinforced silicone elastomer intended to be implanted to replace the first metatarsophalangeal (big toe) joint. This generic type of device consists of a single flexible across-the-joint component that prevents dislocation in more than one anatomic plane.
(b)
Classification.
Class II.