[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR888.3025]

[Page 475-476]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 888--ORTHOPEDIC DEVICES--Table of Contents
 
                      Subpart D--Prosthetic Devices
 
Sec. 888.3025  Passive tendon prosthesis.

    (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.

[[Page 476]]

    (b) Classification. Class II.