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The subject humeral stem is a single-use, sterile device intended for use in shoulder replacement. It is intended for the reconstruction of the proximal himmorus. This humeral stem is intended for primary or revision reconstruction of the shoulder joint.

For use as a Bipolar Shoulder Replacement:

• Aseptic necrosis of the humeral head.
• Painful, disabling joint disease of the shoulder resulting from: Degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.
• Proximal humeral fracture and/or dislocation.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Pathological conditions or age considerations which indicate a more conservative glenoid procedure and avoidance of the use of bone cement in the glenoid.

For use as a Total Shoulder Replacement:

• Aseptic necrosis of the humeral head.
• Painful, disabling joint disease of the shoulder resulting from: Degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.
• Proximal humeral fracture and/or dislocation.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure.

The Solar® PureFix® HA Shoulder is a proximal humeral stem manufactured from titanium alloy. The proximal section of the stem is coated with commercially pure titanium (CP-Ti) and hydroxyapatite. The Solar® PureFix® HA Shoulder is available in 11 sizes with distal diameters ranging from 7mm to 17mm in 1mm increer es without Solar® PureFix® HA Shoulder features a taper that is compatible with the Salar® Shoulder lines of humeral heads currently marketed by Howmedica Osteonics.

This document, a 510(k) summary for the Solar® PureFix® HA Shoulder, does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

A 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, rather than presenting novel performance studies against specific acceptance criteria.

Here's why the requested information is not present:

• Acceptance Criteria & Reported Device Performance: This type of information is typically found in design validation or verification reports, which are part of the larger 510(k) submission but are not usually included in the publicly available 510(k) summary. The summary focuses on similarities to a predicate device.
• Sample Size for Test Set & Data Provenance: Not applicable for a substantial equivalence claim based on design and material similarities.
• Number of Experts & Qualifications / Adjudication Method: These apply to studies involving human interpretation or clinical endpoints, which are not detailed in this summary.
• MRMC Comparative Effectiveness Study: Also not applicable, as this is not a study comparing diagnostic accuracy or clinical outcomes of the device.
• Standalone Performance: While performance data would have been generated during design validation, the summary itself doesn't detail it.
• Type of Ground Truth: Not applicable in this context.
• Training Set Sample Size & Ground Truth: This refers to machine learning models, which are not relevant to this type of medical device submission.

The document mainly focuses on:

• Device Description: What the device is made of and its features.
• Intended Use & Indications: For what conditions the device is used.
• Substantial Equivalence Claim: Stating that the device is similar in design, materials, and intended use to a previously cleared device (Solar® Shoulder, K955731).

To obtain the information you requested, you would typically need to review the full 510(k) submission or other design control documentation from the manufacturer, which is usually proprietary.

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