(76 days)
Not Found
Not Found
No
The device description and performance studies focus solely 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
Explanation: The device, a humeral stem, is used in hemiarthroplasty to repair proximal humeral fractures and improve glenohumeral joint stability, which are therapeutic interventions.
No
Explanation: The description states that the device is a metallic humeral component intended for use in hemiarthroplasty, and it describes its physical characteristics and how it is used as an implant. There is no mention of it being used to diagnose a condition or illness.
No
The device description clearly describes a metallic humeral component (a physical implant) and its features, indicating it is a hardware medical device, not software-only.
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 Select Shoulder Humeral Stem is a metallic implant intended for surgical use in the shoulder joint. It is a physical component used within the body, not a test performed on a sample outside the body.
- Intended Use: While the "Intended Use / Indications for Use" section is listed as "Not Found," the "Device Description" and "Anatomical Site" information strongly indicate a surgical implant for orthopedic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or any other activities associated with in vitro diagnostics.
Therefore, the Select Shoulder Humeral Stem is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Not Found
Product codes
Not Found
Device Description
The Select Shoulder Humeral Stem is a metallic humeral component manufactured from cobalt chrome alloy (CoCrMo) and is intended for use either with or without bone cement in hemiarthroplasty. The humeral stem is available in a variety of sizes and lengths and features a proximally grit blasted surface (except for the head stem taper) for biologic or cement fixation. The proximal trapezoidal shape tapers in the A-P plane, thus providing for a stable cement mantle. 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 of proximal humeral 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 in a variety of sizes and heights for increased stability of the glenohumeral joint.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint humeral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Fatigue analysis and taper testing of the Select Shoulder Humeral Stem indicated that the device would survive physiologic loading.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.
0
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 humeral (hemi-shoulder) metallic uncemented
prosthesis - 21 CFR 888.3690 |
| 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 either with or without bone cement in hemiarthroplasty. The humeral stem is available in a variety of sizes and lengths and features a proximally grit blasted surface (except for the head stem taper) for biologic or cement fixation. The proximal trapezoidal shape tapers in the A-P plane, thus providing for a stable cement mantle. 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 of proximal humeral 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 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 & Nephew Richards Cofield Shoulder.
121
C7 D