(78 days)
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No
The device description focuses on the mechanical properties and design of a metallic humeral stem for shoulder arthroplasty, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a humeral stem for total shoulder arthroplasty, which is a surgical procedure to restore function and alleviate pain in the shoulder joint, thus providing a therapeutic effect for patients suffering from conditions requiring total shoulder replacement.
No
This device is a prosthetic implant (humeral stem) intended for use in total shoulder arthroplasty, not for diagnosing medical conditions.
No
The device description clearly describes a physical, metallic implant (humeral stem) intended for surgical implantation, not a software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description clearly states that the Select Shoulder Humeral Stem is a metallic humeral component intended for use in total shoulder arthroplasty. This is a surgical implant used to replace a damaged shoulder joint.
- Lack of IVD Characteristics: The description does not mention any interaction with biological specimens outside the body, analysis of samples, or providing diagnostic information based on such analysis.
Therefore, the Select Shoulder Humeral Stem is 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 Stem is a metallic humeral component manufactured from cobalt chrome alloy (CoCrMo) and is intended for use with bone cement in total shoulder arthroplasty. The humeral stem is available in a variety of sizes and features a proximally grit blasted surface (except for the head stem taper) for enhanced cement fixation. The proximal trapezoidal shape tapers in the A-P plane, thus providing for a stable cement mande. The proximal body also features an antirotation fin on the lateral aspect. Suture holes are provided in the medial proximal body and lateral fin to allow for soft tissue/bony fragment attachment and tensioning, thus resulting in a more biomechanically stable construct for repair for proximal fractures. A male IOI morse type taper permits attachment of one of the metallic humeral heads offered by Intermedics Orthopedics. This taper is identical to the taper of the previously cleared Select Shoulder System. Distally, the stem is rounded and fluted to provide enhanced fixation and rotational stability. The distal stem tip is designed to accept a cement centralizer. The humeral stem is designed for use with Intermedics Orthopedics humeral heads and glenoid components in a variety of sizes and heights 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
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Fatigue analysis and taper testing of the Select Shoulder Humeral Stem indicated that the device would survive physiologic loading.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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.”
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3 SEP
510(k) SUMMARY
June 6, 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 System CoCr Humeral Stem.
| Submitter: | Intermedics Orthopedics, Inc.
9900 Spectrum Drive
Austin, TX 78717
(512) 432-9900 |
|----------------------|---------------------------------------------------------------------------------------------|
| Contact Person: | Jacquelyn Hughes
Manager, Regulatory Affairs |
| Classification Name: | Shoulder joint metal/polymer non-constrained cemented
prosthesis - 21 CFR Part 888.3650 |
| | Shoulder joint metal/polymer semi-constrained cemented
prosthesis - 21 CFR Part 888.3660 |
| Common/Usual Name: | Humeral Stem |
| Trade/Proprietary: | Select® Shoulder CoCr Humeral Stem |
Product Description/Substantial Equivalence:
The Select Shoulder Humeral Stem is a metallic humeral component manufactured from cobalt chrome alloy (CoCrMo) and is intended for use with bone cement in total shoulder arthroplasty. The humeral stem is available in a variety of sizes and features a proximally grit blasted surface (except for the head stem taper) for enhanced cement fixation. The proximal trapezoidal shape tapers in the A-P plane, thus providing for a stable cement mande. The proximal body also features an antirotation fin on the lateral aspect. Suture holes are provided in the medial proximal body and lateral fin to allow for soft tissue/bony fragment attachment and tensioning, thus resulting in a more biomechanically stable construct for repair for proximal fractures. A male IOI morse type taper permits attachment of one of the metallic humeral heads offered by Intermedics Orthopedics. This taper is identical to the taper of the previously cleared Select Shoulder System. Distally, the stem is rounded and fluted to provide enhanced fixation and rotational stability. The distal stem tip is designed to accept a cement centralizer. The humeral stem is designed for use with Intermedics Orthopedics humeral heads and glenoid components in a variety of sizes and heights for increased stability of the glenohumeral joint.
Fatigue analysis and taper testing of the Select Shoulder Humeral Stem indicated that the device would survive physiologic loading.
The Select Shoulder CoCr Humeral Stem is similar to those of the Depuy Global Total Shoulder System, the Biomet Bio-Modular Total Shoulder, the Zimmer Fenlin Total Shoulder, the Kirschner Integrated Shoulder System, the 3M/Orthomet Neer II Shoulder System, and the Smith
1
& Nephew Richards Cofield Shoulder.
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