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The Aequalis Ascend Modular Reverse Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and nonrepairable rotator cuff-tear with pain disabled by:

• Rheumatoid arthritis
• Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
• Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis
• Revision of the devices if sufficient bone stock remains
  The Reverse Metaphysis and Assembly Screw or the Reverse Metaphysis, Reverse Spacer, and Reverse Spacer Assembly Screw are indicated for use as components of the Aequalis Ascend Modular Reverse total shoulder replacement and for transformation of the Aequalis Ascend Anatomic shoulder into a reverse shoulder prosthesis without the removal of the Diaphyseal stem during revision surgery for patients with a functional deltoid muscle. The components are permitted to be used in the transformation from anatomic to reverse if:
• The Diaphyseal stem is well fixed
• The patient has a functional deltoid muscle
• The arthropathy is associated with a massive and non-repairable rotator cuff-tear.
  Notes:
• All components are single use
• The humeral stem is intended for cemented or cementless use
• The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.

The Aequalis Ascend Modular Reverse shoulder prosthesis is a component of semi-constrained reverse shoulder prosthesis.
The Aequalis Ascend Modular Reverse Shoulder system is supplied in separate sterile packages which will be assembled in the operating room. The components provided are:

• The Modular Reverse Metaphysis and Modular Reverse Assembly Screw
• The Modular Reverse Inserts
• An optional Modular Reverse Spacer and Modular Reverse Spacer Assembly Screw can be used when maximum insert thickness does not achieve sufficient tension.
• When the Modular Reverse Spacer is implanted, the Modular Reverse Spacer Assembly Screw will be used in place of the Modular Reverse Assembly Screw.
  The present device submission corresponds to changes made to the version of the device cleared in 510(k) K110599.

The provided text describes a medical device called the "Aequalis Ascend Modular Reverse Shoulder System" and its indications for use, but it does not contain information about acceptance criteria for a study, performance metrics, or study details such as sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment.

The document is a 510(k) premarket notification letter from the FDA to Tornier, Incorporated, confirming substantial equivalence to a predicate device. It outlines the device's classification, indications for use, and a summary of safety and effectiveness information, which primarily focuses on non-clinical testing (fatigue and insert disassembly testing) to demonstrate substantial equivalence to a legally marketed predicate device (Tornier Aequalis Ascend Modular Reverse Shoulder System, K110599).

Therefore, I cannot fulfill your request for the detailed table and study information as the provided text does not contain that level of detail regarding device performance or clinical study methodologies.

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