Musculoskeletal News Roundup 19-Jan-18

January 19, 2018 | Blake Mossy

REGULATORY

BioPoly received CE Mark approval from the FDA for its BioPoly RS Partial Resurfacing Trachlea system, offering treatment options for focal cartilage defects in the femoral condyles, trochlear facets, trochlear groove, and patella. The system is designed to be patient specific, address a range of defect sizes and variations and the procedure is minimally invasive and tissue sparing.

Centric Medical received 510(k) clearance from the FDA for its Cannulated Screw Internal Fixation System, indicated for use in foot/ankle reconstruction. The low profile, titanium alloy system offers partially and fully threaded options in a range of diameters and lengths.

Episurf Medical received approval from the Israeli Ministry of Health to market its Episealer Knee products, and entered into a distribution agreement for the region with AMI Technologies. The devices are designed for the treatment of localized cartilage damage of the knee.

OrthoXel received 510(k) clearance and CE Mark approval from the FDA for its Apex Tibial Nailing System, an intramedullary nail, designed to stimulate callus formation during fracture fixation and includes a range of locking options for torsional stability.  The reusable implantation kit aims to allow for fast and reliable nail implantation in any locking mode, including: standard cross-locking, true rigid fixation with multiple proximal screw clamping and dynamization locking.

FUNDING

Hospital for Special Surgery announced its investment in Sectra, an international medical imaging IT and cybersecurity company that offers a 3D pre-operative planning solution. The software aims to provide orthopedic surgeons with tools to enhance visualization of complex cases while improving patient outcomes.  The system allows surgeons to render standard CT images into a three-dimensional interactive image that can be segmented, manipulated, mirror, templated and 3D printed.

INTELLECTUAL PROPERTY

Ceterix Orthopaedics received a patent from the United States Patent and Trademark Office (USPTO) covering its method to place a suture around a tear in support of meniscus repair. The company’s NovoStitch Plus Meniscal Repair System aims to allow the surgeons to work within the compartment to place a stabilizing circumferential compression stitch around a meniscus repair.

Merete received a patent from the USPTO covering the company’s compression locking fixation plate. The system is a novel bone plate that provides constant compression and locking with a single-hole, one-screw design.

Orthocell received a patent from the USPTO for its CelGro soft tissue reconstruction platform, covering the method of suture-less repair of soft tissue defects. Suture-free repair of soft tissue has potential to improve the efficiency and efficacy of surgical procedures such as tendon, ligament and nerve repair.

CLINICAL

X-Bolt Orthopaedics announced enrollment in its WHITE Four randomized trial run by Oxford University’s Clinical Trials and Research Unit, comparing extracapsular hip fracture fixation devices. The system is designed for strong fixation and aims to reduce reoperation rates.