---

21 C.F.R. § 888.3720   Toe joint polymer constrained prosthesis.

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 888—ORTHOPEDIC DEVICES
Subpart D—Prosthetic Devices

Browse Previous |  Browse Next

§ 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.

Browse Previous |  Browse Next