21 C.F.R. § 888.3720

Toe joint polymer constrained prosthesis.

Last amended: 2016Year: 2026Length: 57 wordsSubsections: 2Official source

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.
21 C.F.R. § 888.3720: Toe joint polymer constrained prosthesis. | Justis AI