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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.
This document describes a 510(k) summary for a medical device called "Select® Shoulder Keeled All-Poly Glenoids." It focuses on the product description and substantial equivalence to previously marketed devices.
Therefore, the provided text does not contain any information regarding acceptance criteria, study details, performance metrics, ground truth establishment, or sample sizes as typically required for evaluating AI/algorithm performance.
The document is a regulatory submission demonstrating substantial equivalence to existing devices in the market, not a study reporting on the performance of an algorithm or an AI system. It describes the physical characteristics and design of the glenoid components and their intended function, asserting their similarity to other approved shoulder systems.
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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 DriveAustin, TX 78717(512) 432-9900 |
|---|---|
| Contact Person: | Jacquelyn HughesRegulatory 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.
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