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The DePuy Global C.A.P.™ CTA Resurfacing Shoulder prosthesis is intended for use in hemi-shoulder arthroplasty.

The DePuy Global C.A.P.™ CTA Resurfacing Shoulder is indicated for hemi-shoulder replacement in patients with rotator cuff tears and arthritis. Specific indications include:

1. Rotator cuff tear arthropathy.
2. Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate.

CAUTION: The DePuy Global C.A.P.™ CTA Resurfacing Shoulder is intended for cementless use only.

The DePuy Global C.A.P.™ CTA Resurfacing Shoulder is a conservative Cuff Tear Arthropathy (CTA) device designed for resurfacing of the humeral head (hemi-shoulder). Resurfacing requires less bone and cartilage removal than is required in total shoulder replacement. Because bone stock is preserved, future revision or arthrodesis can be more easily performed. The prosthesis is intended for uncemented (i.e., press-fit) fixation, and is designed to mimic the normal humeral head geometry.

Composed of a cobalt-chrome-molybdenum alloy (ASTM F-75), the DePuy Global C.A.P.™ CTA Resurfacing Shoulder is available in a variety of diameters. The proposed implant will be available in curvatures of 40, 44, 48, 52 and 56mm, with head heights of 15mm (40 and 44mm curvatures), 18mm (all curvatures) or 21mm (48, 52 and 56mm curvatures).

The proposed humeral head is a one-piece shell, manufactured from cobalt-chrome-molybdenum alloy (ASTM F-75). The inner surface of the dome, or humeral head, has a cobalt-chrome-molybdenum porous coating. The stem has a cobalt-chrome-molybdenum porous coating proximally and is glass bead blasted distally. The distal stem has a cruciate design with a tapered distal tip. A thin layer of plasma-sprayed hydroxyapatite (Duofix™) has been applied to the inner surface of the dome and proximal stem.

The hydroxyapatite (HA) coating applied to the DePuy Global C.A.P.™ CTA Resurfacing Shoulder is substantially equivalent to the HA coating process used in previously cleared products (e.g., DePuy Global C.A.P.™ Resurfacing Replacement Shoulder, K031971; DePuy Global C.A.P.™ HA Resurfacing Shoulder Humeral Heads, K033516). The composition of the coating is the same as that used for previously cleared products, (e.g., DePuy Global C.A.P.™ Resurfacing Replacement Shoulder, K031971; DePuy Global CAP™ HA Resurfacing Shoulder Humeral Heads, K033516).

The DePuy Global C.A.P.™ CTA Resurfacing Shoulder features an extended articulation surface to cover the superior-lateral aspect of the resurfacing head. This additional material keeps the implant surface in contact with the coracoacromial arch for a longer period of time during abduction.

This device also features a stem with a distal cruciate press fit to provide initial fixation. For long-term fixation and implant support, a surface-to-surface contact between the underside of the cup and the humeral head is created because of a flat located on the underside of the cup. Fixation is also provided by biological tissue in-growth into the porous coating.

I am sorry, but the provided text does not contain information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a device. The document is a 510(k) summary for a medical device (DePuy Global C.A.P.™ CTA Resurfacing Shoulder) and focuses on describing the device, its intended use, indications for use, and establishing substantial equivalence to previously cleared predicate devices. It does not include a performance study with acceptance criteria.

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