21 CFR § 888.3720 Orthopedic Devices

§ 888.3720 Toe joint polymer constrained prosthesis.

Current through Sep 8, 2026 · Read all of Part 888

(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.

← § 888.3695 Shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis.§ 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis. →