Mortise Medical Receives FDA Clearance for SyndesMetrics™ Syndesmosis Repair System
LOGAN, Utah, November 14, 2017 – Mortise Medical, a start-up medical device company focused on advanced soft tissue repair systems for ankle injuries, announces that it has recently received FDA 510(k) clearance for its innovative SyndesMetricsÔ Syndesmosis Repair System.
The Mortise Medical SyndesMetricsÔ Syndesmosis Repair System was developed to address three clinical needs for syndesmotic disruption injuries: predictable and repeatable anatomic reduction, restoration of physiological motion, and restoration of ankle stability. Anatomic reduction is achieved using the SyndesMetricsÔ Reduction Clamp, which features: anatomic referencing clamp points; precision, surgeon controlled, calibrated clamping force; and an integrated drill guide to prepare the bone for the SyndesMetricsÔ implant system. Both the SyndesMetricsÔ Reduction Clamp and implant system are compatible with distal fibula plating systems. Also, the SyndesMetricsÔ implant system features minimal hardware prominence, no suture prominence and a reversible locking mechanism for securing the high strength suture tape that connects the tibial and fibular implant components.
Based on biomechanical testing on matched pair human cadaveric ankle specimens at the University of Iowa, the SyndesMetricsÔ implant system was found to more closely reproduce normal physiological ankle motion when compared to a 4.5mm cortical screw or a suture button construct.1 Additionally, mechanical testing conducted by a third party medical device testing company demonstrated that SyndesMetricsÔ repair constructs had higher static strength and higher fatigue strength than 3.5mm cortical screw or suture button repair constructs.2
“Surgeons will find this innovative system more intuitive to use and more reproducible for positioning and tensioning the distal tibiofibular syndesmosis than anything we now have available,” states Dr. Charles L. Saltzman, Professor and Chairman of Orthopaedics at the University of Utah and immediate past President of the International Federation of Foot and Ankle Societies.
Mortise Medical is a medical device company incubated and operated by Surgical Frontiers.
1 Goetz JE, et al., Annual Meeting of the American Society of Biomechanics, 2017
2 Data on file