[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR888.3150]

[Page 460]
 
                        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. 888.3150  Elbow joint metal/polymer constrained cemented prosthesis.

    (a) Identification. An elbow joint metal/polymer constrained 
cemented prosthesis is a device intended to be implanted to replace an 
elbow joint. It is made of alloys, such as cobalt-chromium-molybdenum, 
or of these alloys and of an ultra-high molecular weight polyethylene 
bushing. The device prevents dislocation in more than one anatomic plane 
and consists of two components that are linked together. This generic 
type of device is limited to those prostheses intended for use with bone 
cement (Sec. 888.3027).
    (b) Classification. Class II. The special controls for this device 
are:
    (1) FDA's:
    (i) ``Use of International Standard ISO 10993 `Biological Evaluation 
of Medical Devices--Part I: Evaluation and Testing, ' ''
    (ii) ``510(k) Sterility Review Guidance of 2/12/90 (K90-1),''
    (iii) ``Guidance Document for Testing Orthopedic Implants with 
Modified Metallic Surfaces Apposing Bone or Bone Cement,''
    (iv) ``Guidance Document for the Preparation of Premarket 
Notification (510(k)) Application for Orthopedic Devices,''
    (v) ``Guidance Document for Testing Non-articulating, `Mechanically 
Locked' Modular Implant Components,''
    (2) International Organization for Standardization's (ISO):
    (i) ISO 5832-3:1996 ``Implants for Surgery--Metallic Materials--Part 
3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,''
    (ii) ISO 5832-4:1996 ``Implants for Surgery--Metallic Materials--
Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,''
    (iii) ISO 5832-12:1996 ``Implants for Surgery--Metallic Materials--
Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,''
    (iv) ISO 5833:1992 ``Implants for Surgery--Acrylic Resin Cements,''
    (v) ISO 5834-2:1998 ``Implants for Surgery--Ultra High Molecular 
Weight Polyethylene--Part 2: Moulded Forms,''
    (vi) ISO 6018:1987 ``Orthopaedic Implants--General Requirements for 
Marking, Packaging, and Labeling,''
    (vii) ISO 9001:1994 ``Quality Systems--Model for Quality Assurance 
in Design/Development, Production, Installation, and Servicing,'' and
    (viii) ISO 14630:1997 ``Non-active Surgical Implants--General 
Requirements,''
    (3) American Society for Testing and Materials':
    (i) F 75-92 ``Specification for Cast Cobalt-28 Chromium-6 Molybdenum 
Alloy for Surgical Implant Material,''
    (ii) F 648-98 ``Specification for Ultra-High-Molecular-Weight 
Polyethylene Powder and Fabricated Form for Surgical Implants,''
    (iii) F 799-96 ``Specification for Cobalt-28 Chromium-6 Molybdenum 
Alloy Forgings for Surgical Implants,''
    (iv) F 981-93 ``Practice for Assessment of Compatibility of 
Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of 
Material on Muscle and Bone,''
    (v) F 1044-95 ``Test Method for Shear Testing of Porous Metal 
Coatings,''
    (vi) F 1108-97 ``Specification for Titanium-6 Aluminum-4 Vanadium 
Alloy Castings for Surgical Implants,''
    (vii) F 1147-95 ``Test Method for Tension Testing of Porous Metal 
Coatings, '' and
    (viii) F 1537-94 ``Specification for Wrought Cobalt-28 Chromium-6 
Molybdenum Alloy for Surgical Implants.''

[65 FR 17147, Mar. 31, 2000]