Title 21

SECTION 888.3720

888.3720 Toe joint polymer constrained prosthesis.

§ 888.3720 Toe joint polymer constrained prosthesis.

(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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