(79 days)
The Cofield2 Total Shoulder System is indicated for the following:
Proximal Humeral Prosthesis
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- Complex, acute fractures or fracture-dislocations of the humeral head (e.g. frauma three and four-part injuries in the Neer classification or head splitting, or head impression fractures).
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- Complex, chronic fractures or fracture-dislocations of the humeral head with malunion, non-union of a small osteoporotic head fragment, or chronic dislocation with loss of humeral head cartilage, or large impression fractures.
- Avascular necrosis with intact glenoid cartilage.
- Selected patients with arthritis who do not have adequate scapular bone to support a glenoid component or must engage in moderately heavy activities.
Total Shoulder Arthroplasty
Severe destruction of the glenohumeral articular surfaces with intractable chronic pain in rheumatoid arthritis, juvenile rheumatoid arthritis, osteoarthritis, traumatic arthritis, cuff tear arthroplasty, ancient septic arthritis, avascular necrosis with secondary glenoid changes, radiation necrosis, and other failed reconstructive procedures.
The Cofield Total Shoulder System includes porous coated devices which are intended for use without bone cement, and are single use devices.
The overall design, components, and materials of the Cofield Total Shoulder System are substantially equivalent to the existing components of the Cofield Total Shoulder System cleared under previous cquirvation to the 'existing components of between the subject components of the Cofield Total Shoulder premanet notified on the currently is the intended use of the system without bone cement.
The provided text describes a 510(k) premarket notification for the Smith & Nephew Cofield2 Total Shoulder System. This document focuses on demonstrating substantial equivalence to previously cleared devices for the purpose of market clearance. It does not present a study designed to establish acceptance criteria or demonstrate device performance against those criteria in a clinical or analytical setting.
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The information typically associated with acceptance criteria and a detailed performance study (such as sample size, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies) is not present in this type of regulatory submission summary.
This document is a declaration of intent to market, asserting similarity to existing devices, rather than a detailed report of a performance study with defined acceptance criteria.
§ 888.3670 Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits movement in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys such as cobalt-chromium-molybdenum (Co-Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al-4V) alloys, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, or a combination of an articulating ultra-high molecular weight bearing surface fixed in a metal shell made of alloys such as Co-Cr-Mo and Ti-6Al-4V. The humeral component and glenoid backing have a porous coating made of, in the case of Co-Cr-Mo components, beads of the same alloy or commercially pure titanium powder, and in the case of Ti-6Al-4V components, beads or fibers of commercially pure titanium or Ti-6Al-4V alloy, or commercially pure titanium powder. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis.”