§ 888.3025. Passive tendon prosthesis.
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/us/cfr/t21/s§ 888.3025·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A passive tendon prosthesis is a device intended to be implanted made of silicon elastomer or a polyester reinforced medical grade silicone elastomer intended for use in the surgical reconstruction of a flexor tendon of the hand. The device is implanted for a period of 2 to 6 months to aid growth of a new tendon sheath. The device is not intended as a permanent implant nor to function as a replacement for the ligament or tendon nor to function as a scaffold for soft tissue ingrowth.
(b)Classification. Class II.