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The Double Internal Joint Stabilizer - Elbow is intended to provide temporary stabilization of the elbow joint after trauma or chronic elbow dislocation.

The Predicate Internal Joint Stabilizer - Elbow (IJS-E) System consists of a titanium base plate, with the following components: A Distal Connecting Rod and Proximal Connecting Rod, held together by adjustable locking joints and locking screws which allow for multiple degrees of freedom. The Proximal Connecting Rod is secured to the distal humerus at the axis of rotation using a cobalt chrome axis pin provided in multiple lengths from 30mm to 70mm in 5mm increments. The subject Double Internal Joint Stabilizer - Elbow (IJS-E) System is modifying the predicate IJS-E Base Plate to add an additional set of components to the other side of the IJS-E Base plate. The Proximal Connecting Rods from each side of the Double IJS-E base plate are secured to the distal humerus at the axis of rotation using the predicate male axis pin from one side and the new female axis pin from the other side. The male axis pin telescopes within the female axis pin within the distal humerus. The subject Double Internal Joint Stabilizer - Elbow Base Plate is attached to the Ulna by the same 3.5mm compression screws as the predicate IJS-E system (K153208). The modified system provides internal stabilization to the elbow joint in the same manner, function, and technology as the Company's cleared Internal Joint Stabilizer - Elbow. The system includes specialized instrumentation. The system is provided non-sterile and is sterilized in the user facility.

The Internal Joint Stabilizer- Elbow is intended to provide temporary stabilization of the elbow joint after trauma or chronic elbow dislocation.

The Skeletal Dynamic's Internal Joint Stabilizer Elbow System (K153208) consists of a titanium base plate, with a Distal Connecting Rod and Proximal Connecting Rod, held together by adjustable locking joints and locking screws which allow for multiple degrees of freedom. The system is being modified to include an Internal Joint Stabilizer - Elbow titanium base plate applied to the Company's cleared Proximal Ulna Plates of the Distal Elbow Plating System (K171590), instead of directly to the ulna as does the base plate of the cleared Internal Joint Stabilizer Elbow System. The subject Internal Joint Stabilizer- Elbow is attached to the cleared Proximal Ulna Plates by means of two #4-40 cobalt chrome screws of 5.5mm in length and the Proximal Connecting Rod is secured to the distal humerus at the axis of rotation using the cleared cobalt chrome axis pin provided in multiple lengths from 30mm to 70mm in 5mm increments. The modified system provides internal stabilization to the elbow joint in the same manner, function, and technology as the Company's cleared Internal Joint Stabilizer Elbow. The system includes specialized instrumentation. When attached to the cleared Skeletal Dynamics proximal ulna plate, the Internal Joint Stabilizer Elbow sits on the same anatomical location over the ulna and under the musculature and soft tissue, as does the cleared Internal Joint Stabilizer - Elbow. The system is provided non-sterile and is sterilized in the user facility.

The Internal Joint Stabilizer – Elbow is intended to provide temporary stabilization of the elbow joint after trauma or chronic elbow dislocation.

The Skeletal Dynamics Internal Joint Stabilizer – Elbow is an internal elbow fixator, with three principal components: - A Base Plate assembly consisting of a low profile Base Plate, contoured to fit within . the flat surface of ulna at the olecranon process; a Connecting Rod, a Boom and two Locking Joints designed to bridge over the anconeous muscle. The Connecting Rod and Boom are adjustable by means of the Locking Joints to accommodate different patient anatomies. The Base Plate assembly is made of titanium alloy and cobalt chrome. - A cobalt chrome Axis Pin threads through the Boom of the Base Plate assembly and ● is inserted in the axis of rotation of the humerus, and - . Titanium compression screws to attach the Base Plate Assembly to the ulna. Specialized instrumentation includes Axis Trajectory Guides (available in 3 sizes), K- Wire Guide, K-Wires, Depth Gauges, Drills, a Counter-torque tool, and a T-10 driver and quick connect handle. The Internal Joint Stabilizer - Elbow is intended to be removed once the elbow ligaments have healed, usually within 6 - 8 weeks after implantation. The system is provided non-sterile and is sterilized in the user facility.