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| Repreve expandable screw and fracture plate |
Ankle fracture reconstructed with Simplicity’s Expandable Screws | | |
Simplicity has created a product pipeline of proprietary expandable anchors that have particular benefit over current technology. Initial Company testing demonstrated a 54% increase in holding power compared to conventional fixation methods. These implants allow significant opportunity to create distinctive and improved products that are intended to distinguish Simplicity as an industry leader in orthopedic fixation.
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Unicortical Plate and Screw Fixation Set
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| With the improved holding strength of the screw supplement, only one side of the bone needs to be involved in fixation. The Company expects this to decrease operative time and improve surgical safety, as important structures beyond the opposite cortex are not placed at risk during the drilling process. |
| Small Bone Fracture Fixation Set |
| The Repreve supplement is expected to be advantageous where small screws strip easily due to their miniature thread dimensions. Hand and maxillofacial bones have very thin cortices, making it difficult for screws to obtain fixation. |
| Acetabular Fixation in Total Hip Replacement Surgery |
| The Company believes that the Screw supplement will be beneficial for augmenting acetabular fixation for hip revision surgery where there is significant bone loss due to previous surgery. |
| Specific Problem Fracture Set |
| The Company anticipates that the Screw supplement will be advantageous in specific problem areas such as the distal radius (wrist), pelvis (hip) and calcaneus (foot). |
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Notes:
Simplicity’s Screw Supplement System was granted 510(k) marketing clearance from the U.S. FDA (K032966).
All other products listed will require FDA 510(k) clearance and are not for sale. |