(30 days)
The Copeland Resurfacing Humeral Heads are indicated for the following conditions where the humeral head and neck are of sufficient bone stock and there is presence of an intact or reconstructable rotator cuff which is necessary for proper functioning and dislocation resistance:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis
- Correction of functional deformity
- Reconstructable rotator cuff
- Treatment of fractures of the humeral head
- Traumatic arthritis
For cemented use only.
These devices are cemented and are designed to maintain maximum bone stock by removing minimal bone and replacing only the defective surface. Copeland Resurfacing Humeral Heads can be used in hemi- or total shoulder replacement surgical procedures. By preserving the bone stock, this device gives a patient an alternative to other total shoulder devices where more bone is removed.
The humeral head components are available in four sizes - small, medium, large, and extra-large. The small, medium, and large humeral heads have the same radius of curvature, but the heights differ to cater for the range of anatomical sizes and offsets. The extra-large head has a larger radius of curvature to accommodate a patient with larger bone stock. The stem is tapered and fluted to provide maximum stability in the humerus. The components are manufactured from cobalt-chrome-molybdenum alloy (ASTM F-75) and coated with MacroBond™ (Ti-Al-4V, ASTM F-1580) on the nonarticulating surface.
The small, medium, and large humeral head components can be used with Biomet's BioModular Glendoids or Integrated Glenoids. The extra-large head can only be used with Biomet's BioModular Glenoids due to the larger spherical radius.
The provided documentation is a 510(k) summary for the Copeland Resurfacing Humeral Heads and does NOT contain information about acceptance criteria or a study proving device performance against such criteria.
The document primarily focuses on:
- Device Description: What the device is, its components, materials, and sizes.
- Intended Use: The medical conditions it's designed to treat.
- Potential Risks: General risks associated with joint replacement devices.
- Predicate Device: A similar device previously cleared by the FDA (K003044 - Copeland Resurfacing Heads).
- FDA Clearance Letter: Confirmation that the device has been cleared for marketing based on substantial equivalence to the predicate device.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance because it is not present in the provided text.
To answer your request, information about a specific design validation study, performance metrics, and acceptance thresholds would be required. This type of information is typically found in the full 510(k) submission, specifically in the testing and clinical data sections, which are not included here.
§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.