21 C.F.R. § 888.3770
Wrist joint carpal trapezium polymer prosthesis.
Cite as 21 C.F.R. § 888.3770 (2026)
(a)
Identification.
A wrist joint carpal trapezium polymer prosthesis is a one-piece device made of silicone elastomer or silicone elastomer/polyester material intended to be implanted to replace the carpal trapezium bone of the wrist.
(b)
Classification.
Class II.