Small Bone Innovations, Inc. Announces Its New Lateral rHead For Treatment Of Radial Head Fractures And Diseases In The Elbow
New York, NY - Small Bone Innovations, Inc. (SBi), a single-source provider of innovation, products, technology and education for the small bone and joint sector of the orthopedic industry, has announced the latest technology addition to its growing and impressive family of Elbow Management System products, its new Lateral rHead implant.
The Lateral rHead is comprised of a uniquely designed mechanical couple between the head and stem components. The couple does not require a set screw and is provided with an easy-to-use assembly tool that can be used in vivo or on the "back table" to quickly assemble the head to the stem component.
Similar to SBi's rHead and rHead Recon products, the head and stem components are fully modular. The Lateral rHead head is highly polished cobalt chrome (CoCr). The stem is cobalt chrome (CoCr) with the stem and collar buttress coated with plasma-sprayed commercially pure titanium (CPTi). The Lateral rHead received a 510(k) clearance from the U.S. FDA in December, 2006.
SBi's Lateral rHead provides surgeons with yet another option for treating radial head fractures and disease. The unique design allows for lateral access and placement, which is less invasive in terms of surgical site exposure and soft tissue dissection, minimizing ligamentous release required during the surgical procedure. It also facilitates placement and repair in this restrictive anatomy, requires minimal resection of the lateral collateral ligament (LCL) and preserves the annular ligament.
The new Lateral rHead complements SBi's rHead Recon implant, which facilitates alignment of the radio capitellum and provides for greater anatomic positioning.
SBi's Lateral rHead augments the growing SBi Elbow Management System, a suite of the most comprehensive products and technology systems in the industry designed to treat all conditions of fracture reconstruction and disease management of the elbow. In addition to the new Lateral rHead, this suite of Elbow Management System products also includes:
The rHead Radial Implant System
This modular design accommodates specific patient physiology, with four stem sizes and three head sizes. The stems are designed with a rough finish, yielding a more receptive surface for bony in-growth, with a uniquely shaped and patented curve for accurate medullary canal alignment.
The rHead Recon Radial Implant System
When proper alignment of the proximal radius cannot be achieved, the added flexibility of the rHead Recon can compensate for misalignment. The bipolar design facilitates proper radio capitellar position throughout flexion/extension and forearm rotation.
Both the rHead and the rHead Recon are available as 6mm Extended Collar implants, for use in patients with distally integrated fractures or where poor bone quality makes proper implant/bone interface problematic.
This innovative design does not require the use of spacers or washers like other systems, and promotes stability. They are also available (with a Size 1 implant stem (with a patented, curved stem, in an identical design to the full-size rHead and rHead Recon) for use in very small patient anatomies. Even with a smaller stem geometry, the Size 1 implant can be used with all existing rHead components.
The UNI-Elbow Radio Capitellum Implant
Used for post-traumatic reconstruction, degenerative joint disease, the correction of functional deformities, and for revision procedures where other treatments have failed, the UNI-Elbow is anatomically designed for minimal resection to restore normal articulation. When used in conjunction with the rHead prosthesis, the system represents the first uni-compartmental elbow implant commercially available in the United States.
The implant replaces the Radio Capitellum joint and preserves a normal, healthy ulno-humeral joint and, when implanted using SBi's Precise Guidance Technology (PGT) system, is tissue-sparing and less invasive than performing a total elbow replacement.
AutoFIX Cannulated Compression Screws
Available in 2.0mm and 2.5mm sizes, these stainless steel headless screws are optimal for use in articular surfaces of joints and in areas of minimal soft tissue coverage. An opposing buttress thread design facilitates compression towards fracture/osteotomy.
SOURCE: Small Bone Innovations, Inc.