SELECT SHOULDER CONCENTRIC HUMERAL HEAD COMPONENTS

K962224 · Intermedics Orthopedics · KWS · Aug 28, 1996 · Orthopedic

Device Facts

• Record ID: K962224
• Device Name: SELECT SHOULDER CONCENTRIC HUMERAL HEAD COMPONENTS
• Applicant: Intermedics Orthopedics
• Product Code: KWS · Orthopedic
• Decision Date: Aug 28, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Select Shoulder Humeral Heads are metallic components manufactured from wrought cobalt chrome alloy (CoCrMo). The heads, once impacted onto one of the Select Shoulder humeral stems, are designed to articulate with the normal human glenoid or with a replacement all-poly glenoid component. The humeral heads feature a female taper which allows for attachment to the male taper of the Intermedics Orthopedics Select Shoulder Humeral Stems. The heads are available in a variety of heights and diameters. The humeral heads are designed for use with Intermedics Orthopedics Humeral Stems and/or glenoid components in a variety of sizes for increased stability of the glenohumeral joint.

Device Story

Select Shoulder Concentric Humeral Heads; metallic components (wrought CoCrMo); female taper design for attachment to Intermedics Orthopedics Select Shoulder Humeral Stems; available in various heights/diameters. Used in orthopedic surgery to articulate with natural glenoid or all-poly glenoid replacement. Provides stability to glenohumeral joint. Surgeon-operated in clinical setting. Benefit: joint stability and articulation restoration.

Clinical Evidence

Bench testing only. Testing included pulloff strength measurements and contact area analysis at various levels of abduction to ensure performance comparable to currently marketed devices.

Technological Characteristics

Material: wrought cobalt chrome alloy (CoCrMo). Design: modular humeral head with female taper for attachment to humeral stems. Available in multiple heights and diameters. No software or electronic components.

Indications for Use

Indicated for patients requiring shoulder joint replacement, specifically for articulation with the normal human glenoid or a replacement all-poly glenoid component to increase stability of the glenohumeral joint.

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.”

Reference Devices

• Depuy Global Total Shoulder System
• Biomet Bio-Modular Total Shoulder
• Zimmer Fenlin Total Shoulder
• Kirschner/Biomet Modular Shoulder System
• 3M/Orthomet Modular Neer II Shoulder System
• Encore Foundation Shoulder System

Submission Summary (Full Text)

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AUG 28 1996
510(k) SUMMARY
June 7, 1996
K 96 22 24

In accordance with the Food and Drug Administration Interim Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21CFR 807, this is to serve as a 510(k) Summary for the Intermedics Orthopedics, Inc. Select® Shoulder Concentric Humeral Heads.

Submitter: Intermedics Orthopedics, Inc.
9900 Spectrum Drive
Austin, TX 78717
[phone]

Contact Person: Jacquelyn Hughes
Manager, Regulatory Affairs

Classification Name: No formal classification has been established for humeral head components.

Common/Usual Name: Humeral Head Components

Trade/Proprietary: Select® Shoulder Concentric Humeral Heads

Product Description/Substantial Equivalence:

The Select Shoulder Humeral Heads are metallic components manufactured from wrought cobalt chrome alloy (CoCrMo). The heads, once impacted onto one of the Select Shoulder humeral stems, are designed to articulate with the normal human glenoid or with a replacement all-poly glenoid component. The humeral heads feature a female taper which allows for attachment to the male taper of the Intermedics Orthopedics Select Shoulder Humeral Stems. The heads are available in a variety of heights and diameters. The humeral heads are designed for use with Intermedics Orthopedics Humeral Stems and/or glenoid components in a variety of sizes for increased stability of the glenohumeral joint.

Testing indicated that the pulloff strengths for the Select Shoulder Humeral Heads were comparable to currently marketed devices. Contact area testing indicated that the standard heads provide adequate contact area at various levels of abduction.

The Select Shoulder CoCr Humeral Heads are similar to those of the Depuy Global Total Shoulder System, the Biomet Bio-Modular Total Shoulder, the Zimmer Fenlin Total Shoulder, the Kirschner/Biomet Modular Shoulder System, the 3M/Orthomet Modular Neer II Shoulder System, and the Encore Foundation Shoulder System.

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