Search Results

Anatomic Total Shoulder or Hemi-Shoulder

The INHANCE SHOULDER SYSTEM with the humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures to address the following:

• Osteoarthritis
• Post-traumatic arthrosis
• Focal avascular necrosis of the humeral head
• Previous surgeries of the shoulder that do not compromise the fixation

The INHANCE SHOULDER SYSTEM with a humeral stem is intended for use in anatomic total or hemi-shoulder replacement procedures to address the following:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• Rheumatoid arthritis.
• Revision where other devices or treatments have failed.
• Correction of functional deformity.
• Fractures of the humeral head (with Short Humeral Stems)
• Fractures of the proximal humerus (with Standard or Long Stems)
• Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate.

Fixation Methods
The humeral stems are intended for cemented or cementless use. The humeral stemless anchor is intended for cementless use. The glenoid is intended for cemented use only.

The INHANCE™ Hybrid Anatomic Glenoid Implants are offered in five sizes: X-Small (21.5mm), Small (24.0mm), Medium (26.5mm), Large (29.0mm), and X-Large (31.5mm). The Glenoid Implants consist of a Cross-linked, Vitamin E Ultra High Molecular Weight Polyethylene (Cross-linked, VE UHMWPE) articulation surface and fixation ring along with an additively manufactured Ti-6Al-4V (titanium alloy) central fixation post.

The INHANCE™ Hybrid Anatomic Glenoid Implants have a lateral surface that is concave and designed to articulate with the Humeral Heads from the Ignite Anatomic Stemmed and Stemless Shoulder Systems that are indicated for use in total shoulder arthroplasty.

The provided document is a 510(k) summary for a medical device (INHANCE™ Hybrid Anatomic Glenoid Implant) and does not describe a study involving algorithms, AI, or human readers. Therefore, I cannot extract the requested information regarding acceptance criteria and studies that prove a device meets criteria in the context of AI/algorithm performance.

The document focuses on demonstrating substantial equivalence of a new glenoid implant to existing predicate devices based on non-clinical testing of mechanical properties, biocompatibility, and material characteristics.

The following points are explicitly stated in the document:

• Clinical Testing: "Clinical testing was not necessary to demonstrate substantial equivalence of the INHANCE™ Hybrid Anatomic Glenoid Implants to the predicate device."
• Studies performed are non-clinical, mechanical, and material evaluations.

Therefore, the questions regarding acceptance criteria and studies for AI/algorithm performance cannot be answered from the provided text.

Ask a specific question about this device