FusionFrame Instructions for Use

8 Pages

TM  Ring Lock System  INSTRUCTIONS FOR USE FUSIONFRAME RING LOCK SYSTEM Legal Manufacturer:  Distributed by:  GLW, Inc. 300 Sylvan Ave, 2nd Floor Englewood Cliffs, NJ 07632  Novastep Inc. 30 Ramland Road, Suite 200 Orangeburg, NY 10962  1.1 Description  1.3 Contraindications  The FusionFrame Ring Lock System is a circular external fixator that provides a weight bearing scaffold that, in most cases, allows patients to remain mobile throughout the course of treatment. The device is assembled from a selection of discrete components to provide a variety of possible constructs to ensure stability, realignment of bones, application of compressive forces or distraction of bone fragments over a period of time. The FusionFrame consists of externally mounted Rings and ancillary components that are interconnected with Rods. The construct is attached to the bone with a combination of percutaneously applied tensioned Wires. Compression/ distraction struts may be attached to the frame to systematically control the gaps between bone fragments and distances between Rings to manage a variety of pathologies. Threaded Rods or struts may be used to reduce and compress fracture zones and lengthen limbs. Rings, rods and other frame elements are available in a range of sizes.  Surgical procedures other than those listed in the indications section.  1.2 Indications for use The FusionFrame Ring Lock System is used to manage a variety of indications and treatments: • Stabilization of Fractures and Osteotomies. • Bone deformity correction of lower extremities. • Arthrodesis of the rear foot, mid foot and ankle joint. • Limb Lengthening in pediatric patients and adults. 1  IFU001 Version B Dated: Aug 2020  Known or suspected allergy to any materials from which the FusionFrame components are made (especially Wires and Pins). Use of FusionFrame components with components of other origin, not specifically recommended for use with the FusionFrame. Reconstruction of neck and head, spine or back. Articulation joint: Shoulder, elbow, hip, knee. Presence of active infection. Any existing or suspected condition that may prevent or inhibit the patient’s ability or willingness to follow post-operative protocols during the entire treatment and healing process.  1.4 Components  Full Rings, Half-Rings & 5/8 Rings:  The FusionFrame includes four diameters of Ring sizes: 140, 160, 180, and 205mm. All Rings and Half Rings are 8mm thick. Rings provide the scaffolding and structural support for the overall frame and are the primary platform from which all other components are connected. Two Half Rings, bolted together form a full circular Ring. The size is specified by the inside diameter of the Ring. All FusionFrame Rings are made of aluminum. Prior to application, the surgeon must determine the Ring diameters as a function of patient size and anatomical features. Ring size needs to be
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