(79 days)
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No
The device description and performance studies focus on the mechanical properties and articulation of a metallic shoulder implant, with no mention of AI or ML.
Yes
The device is a metallic component designed to articulate with the normal human glenoid or a replacement glenoid component within the shoulder joint. It is used as part of a system with humeral stems and/or glenoid components to increase stability of the glenohumeral joint, which indicates it replaces or supports a damaged or diseased body part to restore function or provide therapy.
No
Explanation: This device, the Select Shoulder Humeral Head, is a metallic implant designed to articulate within the shoulder joint. Its function is to replace or assist existing anatomical structures, not to diagnose a condition. The description focuses on its material, articulation, and various sizes for surgical implantation.
No
The device description clearly states the device is a metallic component (humeral head) made from cobalt chrome alloy, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the device is a metallic component (humeral head) designed to be implanted into the human body as part of a shoulder replacement system. It articulates with the glenoid.
- Intended Use/Indications for Use: While not explicitly stated, the description implies the intended use is for surgical implantation to restore shoulder joint function. This is a therapeutic/surgical device, not a diagnostic one.
- Lack of Diagnostic Information: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health status.
Therefore, the Select Shoulder Humeral Heads are a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
glenohumeral joint
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.”
0
510(k) SUMMARY
June 7, 1996
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
(512) 432-9900 |
|----------------------|--------------------------------------------------------------------------------------------|
| Contact Person: | Jacquelyn Hughes
Manager, Regulatory Affairs |
| Classification Name: | No formal classification has been estabished 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 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.
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.