COFIED MODULAR SHOULDER SYSTEM

K955767 · Smith & Nephew Richards, Inc. · KWS · Apr 8, 1996 · Orthopedic

Device Facts

• Record ID: K955767
• Device Name: COFIED MODULAR SHOULDER SYSTEM
• Applicant: Smith & Nephew Richards, Inc.
• Product Code: KWS · Orthopedic
• Decision Date: Apr 8, 1996
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Cofield Modular Shoulder System is indicated for the following use: Proximal Humeral Prosthesis 1. Complex, acute fractures or fracture-dislocations of the humeral head (e.g., the four-part injuries in the Neer classification, or headsplitting, or head impression fractures). 2. Complex, chronic fractures or fracture-dislocations of the humeral head with malunion, nonunion of a small osteoporotic head fragment, or chronic dislocation with loss of humeral head cartilage, or large impression fractures. 3. Avascular necrosis with intact glenoid cartilage. 4. Selected patients with arthritis who do not have adequate scapular bone to support a glenoid component or who must engage in moderately heavy activities. Total Shoulder Arthroplasty Severe destruction of the glenohumeral articular surfaces with intractable chronic pain in rheumatoid arthritis, juvenile rheumatoid arthritis, osteoarthritis, traumatic arthritis, cuff tear arthroplasty, ancient septic arthritis, avascular necrosis with secondary glenoid changes, radiation necrosis, and other failed reconstructive procedures. The device is intended only for use with bone cement and is a single use device.

Device Story

Modular shoulder system for total shoulder replacement or proximal humeral prosthesis. Components: humeral stem, head, and UHMWPE glenoid. Used in orthopedic surgery for patients with severe glenohumeral joint destruction or complex fractures. Implanted by orthopedic surgeons in hospital settings. Device provides structural replacement of the shoulder joint to alleviate pain and restore function. Intended for single use with bone cement.

Clinical Evidence

No clinical data; safety and effectiveness based on mechanical testing and long history of use of predicate devices in the marketplace.

Technological Characteristics

Humeral components: Co-Cr-Mo alloy. Porous coating: Co-Cr-Mo beads. Glenoid component: UHMWPE. Semi-constrained design. Intended for cemented fixation.

Indications for Use

Indicated for patients requiring proximal humeral prosthesis or total shoulder arthroplasty due to complex acute/chronic fractures, fracture-dislocations, avascular necrosis, or severe glenohumeral destruction from arthritis (rheumatoid, juvenile, osteoarthritis, traumatic, cuff tear, septic, radiation). Contraindicated for use without bone cement.

Regulatory Classification

Identification

A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing 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).

Special Controls

*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: 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,” 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 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,” (vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,” (vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and (viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”

Predicate Devices

• Biomet Biomedular Total Shoulder
• DePuy Global Total Shoulder
• Orthomet 3M Neer II and Modular Shoulder
• Zimmer Fenlin Total Shoulder
• Kirschner Modular II-C
• Intermedics Select Shoulder System

Submission Summary (Full Text)

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K955767

APR - 8 1996

Smith & Nephew Orthopaedic Implant Division

a division of Smith & Nephew Richards Inc.

1450 Brooks Road, Memphis, TN 38116

Telephone: [phone]

Smith & Nephew

Thomas L. Craig
Director, Regulatory and Clinical Affairs
Orthopaedics
Smith & Nephew Richards Inc.
1450 Brooks Road
Memphis, TN 38115
Telephone: [phone]
Fax: [phone]

Summary of Safety and Effectiveness
Smith & Nephew Richards Inc.
Cofield Modular Shoulder System
October 20, 1995

Trade Name - Cofield Modular Shoulder System
Common Name - modular shoulder system
Classification Name - Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis 21 CFR 888.3660

## Substantial Equivalent Information

The Cofield Modular Shoulder System is similar to the following shoulder systems:

1. Biomet Biomedular Total Shoulder
2. DePuy Global Total Shoulder
3. Orthomet 3M Neer II and Modular Shoulder
4. Zimmer Fenlin Total Shoulder
5. Kirschner Modular II-C
6. Intermedics Select Shoulder System

All the devices listed above are indicated for total shoulder replacement and are indicated for use with cement. They are all similar to the design of the Cofield Modular Shoulder. The safety and effectiveness of the Cofield Modular Shoulder are based on the long history of use of these devices in the market place.

## Device Description

The Cofield Modular Shoulder System consists of the following components:

- Stem component
- Head component
- Glenoid UHMWPE component

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K955767

The humeral components are fabricated from Co-Cr-Mo. The porous coating on the undersurface of the collar of the stem is fabricated from Co-Cr-Mo beads. The glenoid component is manufactured from UHMWPE.

## Indications for Use

The Cofield Modular Shoulder System is indicated for the following use:

### Proximal Humeral Prosthesis

1. Complex, acute fractures or fracture-dislocations of the humeral head (e.g., the four-part injuries in the Neer classification, or headsplitting, or head impression fractures).
2. Complex, chronic fractures or fracture-dislocations of the humeral head with malunion, nonunion of a small osteoporotic head fragment, or chronic dislocation with loss of humeral head cartilage, or large impression fractures.
3. Avascular necrosis with intact glenoid cartilage.
4. Selected patients with arthritis who do not have adequate scapular bone to support a glenoid component or who must engage in moderately heavy activities.

### Total Shoulder Arthroplasty

Severe destruction of the glenohumeral articular surfaces with intractable chronic pain in rheumatoid arthritis, juvenile rheumatoid arthritis, osteoarthritis, traumatic arthritis, cuff tear arthroplasty, ancient septic arthritis, avascular necrosis with secondary glenoid changes, radiation necrosis, and other failed reconstructive procedures.

The device is intended only for use with bone cement and is a single use device.

## Mechanical Testing

Mechanical testing was performed according to the requirements of FDA guidance documents and met or exceeded acceptable performance.