SELECT SHOULDER CONCENTRIC HUMERAL HEAD COMPONENTS by INTERMEDICS ORTHOPEDICS

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 Internedics 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.

AI/ML Overview

This 510(k) summary does not contain the information requested in your prompt. It describes a medical device (humeral heads) and claims substantial equivalence to existing devices, but it does not include:

Acceptance criteria for device performance.
Details of a study proving the device meets acceptance criteria.
Information on sample sizes, data provenance, expert qualifications, or adjudication methods for ground truth establishment.
Any mention of AI, standalone algorithms, or multi-reader multi-case comparative effectiveness studies.
Specific ground truth types for training or test sets.

The document primarily focuses on the product description, material, and a qualitative comparison to similar devices, noting "pull-off strengths... comparable" and "adequate contact area," but without specific performance metrics or detailed study methodologies.

Summary

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510(k) SUMMARY

June 7, 1996

K962224)

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 DriveAustin, TX 78717(512) 432-9900
Contact Person:	Jacquelyn HughesManager, Regulatory Affairs
Classification Name:	No formal classification has been estabished for humeralhead components.
Common/Usual Name:	Humeral Head Components
Trade/Proprietary:	Select® Shoulder Concentric Humeral Heads

Product Description/Substantial Equivalence:

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 System, the 3M/Orthomet Modular Neer II Shoulder System, and the Encore Foundation Shoulder System.

Regulation Number and Section

§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

(a)
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).(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: 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.”