Search Results

The Ascend Shoulder System consists of a humeral stem, a mating humeral head, and an optional polyethylene glenoid. The stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The Ascend Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and to relieve pain.

The Ascend Shoulder System is indicated for use as a replacement of shoulder joints disabled by:

• Rheumatoid arthritis with pain
• Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
• Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis
• Revision of other devices if sufficient bone stock remains

All components are single use. The humeral stem is intended for cementless use, while the all polyethylene glenoid is intended for cemented use only.

The Ascend Shoulder System consists of a humeral stem, a mating humeral head and an optional all polyethylene glenoid. The stem and head may be used alone, as a hemiarthroplasty if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total shoulder replacement system.

The present device submission corresponds to changes made to the version of the device cleared in 510(k) K071147.

The provided text describes a Special 510(k) Premarket Notification for the Tornier Inc. Ascend Shoulder System, which is a medical device. This type of submission is for modifications to a previously cleared device and focuses on establishing substantial equivalence to a predicate device, rather than proving device performance against specific acceptance criteria through clinical studies.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not present in the provided document. The document focuses on regulatory classification, device description, indications for use, and a summary of non-clinical testing to demonstrate substantial equivalence to a predicate device (Tornier Nexa Orthopedics Total Shoulder System, K071147).

The non-clinical testing performed includes:

• Taper disassembly strength
• Mismatch evaluation
• Extraction testing
• Cadaveric evaluation

The document explicitly states: "The results of these non-clinical tests allow us to conclude that the Ascend Shoulder System described in this submission is substantially equivalent and as safe and effective as the original device." This indicates that no separate study proving the device meets specific acceptance criteria as defined by performance metrics (like sensitivity, specificity, accuracy, etc.) was conducted or reported in this submission format, as it's not typically required for a Special 510(k) for a modified Class II orthopedic implant.

Ask a specific question about this device