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The Biomet 100% porous coated Biaxial Hinge Total Elbow is indicated for use in rheumatoid arthritis, non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, correction of severe functional deformity, revision procedures where other treatments or devices have failed, and treatment of acute or chronic fractures with humeral epicondyle involvement which are unmanageable using other treatment methods. This linked constrained elbow prosthesis is indicated for joints with both intact and limited soft tissue structure about the elbow.

This device is a single use implant. It is intended for use with bone cement.

The Biomet 100% porous coated Biaxial Hinge Total Elbow Prosthesis is a constrained hinge elbow prosthesis used to replace the humeral-ulnar articulation of the human elbow. The implant consists of two components, an ulnar and a humeral component which are joined by a modular connecting piece.

The Biaxial is a "loose hinge" type that has a parallel acting second axis of articulation between the ulnar and humeral stems. An inherent characteristic of the biaxial articulation is that it can vary the anterior-posterior offset between the intramedullary stems. The Biaxial Elbow allows the stem offset to vary because of varying amounts of flexion between the displaced axes of the prosthesis. The mechanical constraint of the articulation allows a total of 16 degrees of varus valgus movement, 6 degrees of hyperextension, and 188 degrees of flexion.

The humeral component is a titanium alloy stem. The humeral stem incorporates a flange on the anterior side for additional fixation. The entire stem and a portion of the flanges are plasma spray coated. The humeral component utilizes a polyethylene humeral bearing (saddle bearing) to prevent metal on metal contact with the connecting segment.

The ulnar component is a titanium alloy stem. The surface of the ulnar component is plasma spray coated. The ulnar component utilizes a polyethylene ulnar bearing (saddle bearing) to prevent metal on metal contact with the connecting segment.

The modular connecting segment is a cobalt chromium alloy metallic piece with a polished finish. The connecting segment is joined to the humeral and ulnar stems by means of a sleeve bearing metal reinforcing rod or axle and saddle bearing. The metal reinforcing rod or axle is manufactured from cobalt chromium. The axles are sleeved by axle bearings, which are manufactured from ArCom® (ultra high molecular weight polyethylene (UHMWPE)). The axle retaining clips are manufactured from titanium alloy. The saddle bearings of the humeral and ulnar component are manufactured from ArCom®.

This document is a 510(k) premarket notification for a medical device (Biomet 100% porous coated Biaxial Total Elbow). It establishes substantial equivalence to predicate devices and outlines the device's description, intended use, and potential risks. It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria as typically found in clinical trial reports or performance validation studies for AI/software devices.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or types of ground truth for a test set.
• Sample size for the training set or how ground truth for the training set was established.

This document is primarily concerned with regulatory clearance based on substantial equivalence, not a detailed performance study with quantifiable acceptance criteria.

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