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The Humelock II Cemented Shoulder System is indicated for use in total and hemi-shoulder replacement to treat:

1. Proximal humeral fractures
2. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis;
3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a previously implanted primary component, a humeral plate or a humeral nail).

The humeral stem and glenoid components of the Humelock II Cemented Shoulder System are intended for cemented use only.

The Humelock II Cemented Shoulder System is a total and hemi-shoulder prosthesis consisting of a humeral stem, a humeral head, a double taper connector, and, when used for total shoulder replacement, a glenoid component.

The humeral stem is manufactured from Ti-6A1-4V alloy conforming to ISO 5832-3 and is available in diameters of 6-15mm. The humeral stem incorporates a female taper for attachment of the double taper connector, which connects to the humeral head.

The double taper connector is manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3. One size is available and is compatible with all sizes of humeral stems and humeral heads.

The humeral head is manufactured from wrought Co-Cr-Mo alloy conforming to ISO 5832-12 and is available in diameters of 39 - 50mm in centered and offset styles. A female taper allows attachment to the double taper connector, which connects to the humeral stem.

The glenoid component is manufactured from ultra high molecular weight polyethylene (UHMWPE) conforming to ISO 5834-2. It is available in sizes extra small, small, medium, and large. The glenoid component features two pegs for cemented fixation to the glenoid bone. Each peg contains a radiopaque marker manufactured from tantalum conforming to ASTM F560.

The current submission adds bone graft cutting and manipulating instruments and graft trials to the Humelock II Shoulder System.

Bone graft cutting and manipulating instruments and graft trials may be used to cut bone graft from the humeral head and position it around the humeral stem. The bone graft can be used to help position and consolidate the tuberosities in cases with proximal bone loss.

The provided document, K140071, describes a 510(k) premarket notification for the Humelock II Cemented Shoulder System. It explicitly states that "Clinical testing was not necessary to determine substantial equivalence between the Humelock II Cemented Shoulder System and the predicate shoulder systems."

Therefore, based on the provided document, there is no information available regarding acceptance criteria or a study proving the device meets those criteria, as no clinical testing was performed for substantial equivalence.

The document details the device's components, materials, intended use, and a comparison to predicate devices, but lacks any description of a performance study involving a test set, expert readers, ground truth, or statistical analysis.

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