Search Results

1. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction 2. Open and closed fracture fixation 3. Pseudarthrosis of long bones 4. Limb lengthening by distraction 5. Correction of bony or soft tissue deformities 6. Joint arthrodesis 7. Infected fractures 8. Nonunions

The Smith & Nephew Acute QC Strut and Components consist of multiple sized struts (e.g., X Short, Short, Medium, and Long) and components such as nuts, bands, and washers to build an external fixation construct. The proposed devices incorporate design features similar to those currently incorporated in previously cleared Smith & Nephew SMART Taylor Spatial Frame and ILIZAROV™ External Fixation System. The Acute QC Strut and Components will be manufactured from aluminum, composite, and stainless-steel material, which is identical to that of the predicate devices of the SMART Taylor Spatial Frame System (e.g., K210953, S.E. 07/29/2021).

The Deformity Analysis and Correction Software (DACS) and Instrumentation are intended to be used as components of the Smith & Nephew Taylor Spatial Frame external fixation system that is indicated for the following: post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; open and closed fracture fixation; pseudoarthrosis of long bones; limb lengthening by epiphyseal distraction; correction of bony or soft tissue deformities; correction of bony or soft tissue defects; joint arthrodesis; infected fractures or nonunions.

The Deformity Analysis and Correction Software (DACS) and Instrumentation is an optional software component and is used to assist the physician in calculating the lengths of the struts connecting the rings to manipulate the bone fragments. The software receives inputs from the physician and allows the physician to visualize the moving bone position. The program computes the strut lengths necessary to implement any desired translation and/or rotation required by the surgeon. The instrumentation includes Radiopaque Fiducial Markers which are attached to the Smith & Nephew Taylor Spatial Frame external fixator.

The OrthoHub External Fixator Software is used with Smith & Nephew Taylor Spatial Frame (TSF) rings and struts for the treatment of traumatic or reconstructive tibia deformities. It is used to generate a prescription of strut adjustments to provide to the patient. The OrthoHub External Fixator Software is used to assist the clinician in adjusting the Smith & Nephew Taylor Spatial Frame (TSF) External Fixator by creating a patient adjustment schedule. The OrthoHub software receives x-ray images of the deformity and installed fixator hardware and produces a prescription recommending adjustments to the fixator that define a correction path for the deformity. The software is used as an accessory to the commercially available hardware as detailed in the Instructions for Use, specifically, Smith and Nephew's Taylor Spatial Frame rings and struts.

The OrthoHub External Fixator Software is a software program used on a Macintosh Computer. The software is used to generate a prescription which details adjustments required for the treatment of traumatic or reconstructive tibia deformities when using the Smith and Nephew Taylor Spatial Frame External Fixator hardware. Users input orthogonal x-ray images of a patient's deformity taken after installation of the fixator hardware on the patient. The software creates a colored graphical representation of the bones and orthopedic fixator hardware shown in the x-rays, and the user adjusts this graphical representation so that it best matches the underlying x-rays. The user then defines a correction rate, and the software generates a prescription of strut adjustments to correct the deformity. This prescription is provided to the patient for strut adjustment during the prescription period.