Toe joint polymer constrained prosthesis.

21 C.F.R. § 888.3720
in effectEffective: 2024-07-01
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(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.

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