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The components of Bi-Anqular® Shoulder System included in this submission are intended for hemi- or total shoulder joint arthroplasty. Indications for use include:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
2. Rheumatoid arthritis
3. Revision where other devices or treatments have failed
4. Correction of functional deformity
5. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate
6. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate

Devices with surface coatings are indicated for cemented or uncemented biological fixation application. Non-coated (Interlok®) devices and all polyethylene components are indicated for cemented application only.

The Bi-Anqular® Shoulder System is composed of a titanium alloy humeral stem with a modular humeral head which is designed to articulate with an all polyethylene qlenoid component or the natural glenoid bone in a hemi-shoulder configuration. There is no linkage across the joint.

The proximally tapered, collarless stem follows the natural contours of the humeral canal thus promoting evenly distributed stress off-loading. Cylindrical distal stems fill the humeral canal. Proximal fins contribute to rotational stability while suture holes in the fins allow for proximal reconstruction of complex humeral fractures. Durinq insertion, a K-wire can be placed into the version hole in the medial calcar region of the stem to allow exact version control of the component referencing off the patient's forearm.

Proximal porous coating on the humeral stem provides for biological fixation when used without bone cement. Non-porous humeral stems are available for cemented use.

The humeral component utilizes a modular head which is taper-fit onto the stem at the time of surgery.

The all polyethylene glenoid component has an angled triangular shaped keel which can be trimmed during surgery.

The presented document is a 510(k) premarket notification for a medical device, the Bi-Angular® Shoulder System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics.

Therefore, the document explicitly states: "Clinical Testing: None provided."

Based on this, it's not possible to provide the requested information regarding acceptance criteria and performance studies because no clinical studies were conducted or provided in this 510(k) submission. The FDA's determination was based on substantial equivalence to existing predicate devices and non-clinical mechanical testing, not on clinical performance against specific acceptance criteria.

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