Search Results

When used in the Humelock II Cemented Shoulder System: The Humelock II Cemented Shoulder System is indicated for use in total and hemishoulder replacement to treat:

1. Proximal humeral fractures
2. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis;
3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a previously implanted primary component, a humeral plate or a humeral nail).

The humeral stem and glenoid components of the Humelock II Cemented Shoulder System are intended for cemented use only.

TiN coated Heads are not intended for hemi-shoulder arthroplasty

When used with the Humeris™ Shoulder System: In an anatomic shoulder configuration, the Humeris Shoulder System is indicated for use in total and hemi-shoulder replacement to treat:

• A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis;
• Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a previously implanted primary component, a humeral plate or a humeral nail).

TiN coated Heads are not intended for hemi-shoulder arthroplasty.

In a reverse shoulder configuration, the Humeris Shoulder is indicated for primary or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear.

The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The humeral stem of the Humeris Cementless Shoulder is intended for cementless use only. The humeral stem of the Humeris Cemented Shoulder is intended for cemented use only. The glenoid components of the Humeris Shoulder System are intended for cemented use only. The glenoid baseplate component is intended for cementless use with the addition of screws for fixation.

The TiN Coated Humeral Head is a new component for Humelock II total shoulder replacement systems. The TiN Coated Humeral Head has a titanium nitride (TiN) coating, which is applied to the predicate humeral heads made of cobalt chromium molybdenum (CoCr). Compatible components for use with the TiN coated humeral heads to complete the total shoulder replacement construct are the same as those previously cleared compatible components for use with the CoCr humeral heads in the respective predicate devices, including the primary predicate (K123814) and K163669 for the Humeris Shoulder System.

This document is a 510(k) Premarket Notification from the FDA regarding a TiN Coated Humeral Head. It does not describe a study that proves a device meets acceptance criteria for an AI/ML medical device. Instead, it details the substantial equivalence determination for a physical orthopedic implant.

Therefore, I cannot extract the requested information (acceptance criteria table, sample size, expert ground truth, MRMC study, standalone performance, training set details) because this document does not pertain to an AI/ML medical device and does not contain information about a study proving an algorithm's performance.

The document states:

• "Clinical testing was not necessary to determine substantial equivalence of the TiN Coated Humeral Head to the predicate devices." (Page 7)
• The determination is based on the device being "identical to the primary predicate with the only modification of added TiN coating" and a review of "risk analysis, design controls, biocompatibility, wear properties of the TiN coating, and verification and validation activities to demonstrate that the TiN coating does not increase risk and does not raise new questions of safety and effectiveness." (Page 7)

Ask a specific question about this device