---
kind: "section"
citation: "21 C.F.R. § 888.3650"
title: "21"
number: "888.3650"
heading: "Shoulder joint metal/polymer non-constrained cemented prosthesis."
url: "https://uscodex.org/cfr/21/888.3650"
---

# §888.3650. Shoulder joint metal/polymer non-constrained cemented prosthesis.

- (a) **Identification.** A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement ([§ 888.3027](/cfr/21/888.3027.md)).
- (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,” and
    - (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](/cfr/21/part3.md): Wrought Titanium 6-Aluminum 4-Vandium Alloy,”
    - (ii) **ISO 5832-4—** 1996 “Implants for Surgery—Metallic Materials—[Part 4](/cfr/21/part4.md): Cobalt-Chromium-Molybdenum Casting Alloy,”
    - (iii) **ISO 5832-12—** 1996 “Implants for Surgery—Metallic Materials—[Part 12](/cfr/21/part12.md): 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](/cfr/21/part2.md): Moulded Forms,”
    - (vi) **ISO 6018—** 1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
    - (vii) **ISO 9001—** 1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
  - (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 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
    - (v) F 1108-97 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
    - (vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
    - (vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
    - (viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”

## Notes

### Amendments

[52 FR 33702, Sept. 4, 1987, as amended at 65 FR 17148, Mar. 31, 2000]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.

### Source

Source: 52 FR 33702, Sept. 4, 1987, unless otherwise noted.

### Amendments

[52 FR 33702, Sept. 4, 1987, as amended at 65 FR 17148, Mar. 31, 2000]