(59 days)
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No
The device description focuses on the mechanical design and materials of a shoulder implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is described as an implant used to reproduce the function of the natural glenoid in the shoulder, which is a replacement part rather than a device intended for therapy.
No
Explanation: The device description clearly states its function as an implant (Keeled All-Poly Glenoid Component) for shoulder arthroplasty, designed to reproduce the function of the natural glenoid, not to diagnose a condition. The mention of "postoperative evaluation" with x-ray marker pins refers to assessing the implant's position after surgery, not diagnosing a disease.
No
The device description clearly describes a physical implant (glenoid component) made of material (ASTM F648) with specific design features for surgical implantation, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is a "Keeled All-Poly (ASTM F648) Glenoid" intended to "reproduce the function of the natural glenoid" and is "cemented into the subchondral bone of the glenoid cavity." This describes a surgical implant used in vivo (within the body) to replace a joint component.
- Device Description: The description details the physical characteristics and function of a prosthetic glenoid component, not a test or reagent used to examine specimens in vitro (outside the body).
- IVD Definition: In Vitro Diagnostics are defined as medical devices and accessories used to perform tests on specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit this definition.
The information provided describes a surgical implant used in orthopedic surgery, not an IVD.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
The Keeled All-Poly (ASTM F648) Glenoids are one piece designs intended to reproduce the function of the natural glenoid. The design of these glenoid components allows use in the right or left shoulder. The implant is cemented into the subchondral bone of the glenoid cavity providing a cement mantle of approximately 1-2 mm.
The Keeled All-Poly Glenoid Component features curved back with a keel on the medial surface to provide translational and rotational stability to the implant. A circumferential groove around the middle of the keel allows for intraoperative trimming in the event of shallow glenoid anatomy. The concave lateral surface of the glenoid implant accommodates the humeral head. Dovetail cement grooves on either side of the keel provide enhanced cement fixation. Non-constrained and congruent designs will be available to address varying size and stability requirements. Titanium x-ray marker pins have been attached to the inferior and superior aspects to assist in postoperative evaluation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
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
Contact area testing indicates that the Pegged All-Poly Glenoids offer adequate contact area at various levels of abduction.
Key Metrics
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Predicate Device(s)
Orthomet/3M Modular Neer II Shoulder System, Zimmer Fenlin Total Shoulder, Smith & Nephew Richards Cofield Shoulder, Kirschner/Biomet Modular Shoulder, Biomet Bio-Modular Total Shoulder, Depuy Global Total Shoulder System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).(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 “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.”
0
AUG - 9 1996 510(k) SUMMARY
K962238
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 All-Poly Glenoids.
| Submitter: | Intermedics Orthopedics, Inc.
9900 Spectrum Drive
Austin, TX 78717
(512) 432-9900 |
|----------------------|----------------------------------------------------------------------------------------------|
| Contact Person: | Jacquelyn Hughes
Regulatory Affairs Manager |
| Classification Name: | 21 CFR Part 888.3650 - Shoulder joint metal/polymer non-
constrained cemented prosthesis |
| | 21 CFR Part 888.3660 - Shoulder joint metal/polymer semi-
constrained cemented prosthesis |
| Common/Usual Name: | Glenoid prosthesis |
| Trade/Proprietary: | Select® Shoulder Keeled All-Poly Glenoids |
Product Description/Substantial Equivalence:
The Keeled All-Poly (ASTM F648) Glenoids are one piece designs intended to reproduce the function of the natural glenoid. The design of these glenoid components allows use in the right or left shoulder. The implant is cemented into the subchondral bone of the glenoid cavity providing a cement mantle of approximately 1-2 mm.
The Keeled All-Poly Glenoid Component features curved back with a keel on the medial surface to provide translational and rotational stability to the implant. A circumferential groove around the middle of the keel allows for intraoperative trimming in the event of shallow glenoid anatomy. The concave lateral surface of the glenoid implant accommodates the humeral head. Dovetail cement grooves on either side of the keel provide enhanced cement fixation. Non-constrained and congruent designs will be available to address varying size and stability requirements. Titanium x-ray marker pins have been attached to the inferior and superior aspects to assist in postoperative evaluation.
Contact area testing indicates that the Pegged All-Poly Glenoids offer adequate contact area at various levels of abduction.
The designs are substantially equivalent to the glenoids used in the Orthomet/3M Modular Neer II Shoulder System, the Zimmer Fenlin Total Shoulder, the Smith & Nephew Richards Cofield Shoulder, the Kirschner/Biomet Modular Shoulder, the Biomet Bio-Modular Total Shoulder, and the Depuy Global Total Shoulder System.