February 15, 2018 | Blake Mossy
Emerging Implant Technologies (EIT) received 510(k) clearance from the FDA for the expanded use of its EIT Cellular Titanium Cervical Cage to multiple contiguous cervical levels. The system is a 3D printed porous titanium structure designed to with ideal pore shape and size to optimize cell proliferation and bone ingrowth.
PRODUCT INTRODUCTION & UPDATE
Centric Medical launched its ROGUE+, a sterile-packaged hammertoe correction system, designed to provide internal fixation via a dual threaded construct which is inserted between the proximal and middle phalanges in order to allow opposing threads to fixate within the phalangeal canals of the toe to compress the proximal interphalangeal (PIP) joint.
Episurf Medical announced the launch of its patient-specific Episealer implant products, indicated for the treatment of osteochondral lesions of the talus in the ankle. The system is based on the same as the company’s Episealer knee devices, with a patient-specific design based on 3D modeling and medical imaging.
Bioventus announced the extension of its distribution agreement with Seikagaku’s SUPARTZ FX in the U.S. for its hyaluronic acid-based product for the treatment of knee osteoarthritis pain through a 5-injection regimen. Under the terms of the agreement, Bioventus will be the exclusive distributor of SUPARTZ FX in the U.S.
Camber Spine announced the first surgeries using its SPIRA-C Open Matrix Cervical Interbody device, an interbody fusion implant consisting of spiral support arches and Surface by Design technology, designed to increase fusion rates and stabilization. The system utilizes spiral support arches to decrease subsidence by load sharing over the entire endplate, while also maximizing bone graft capacity.
DT MedTech announced the implantation of its Hintermann Series H2 Total Ankle Replacement System, indicated for use as a non-cemented implant outside of the US and as a cemented implant within the US, for the replacement of painful arthritic ankle joints due to primary osteoarthritis, post-traumatic osteoarthritis, or arthritis secondary to inflammatory disease. The system can also be used as a revision for failed ankle replacements or non-union and mal-union of ankle arthrodesis.
Orthofix announced the commencement of a study of its RCStim pulse electromagnetic field (PEMF) device as an adjunct to surgical repair of full thickness rotator cuff tears. The study will evaluate if PEMF technology that is currently used to promote bone growth can reduce the rate of repaired tendons being subsequently torn again and improve overall patient outcomes.
Spineology announced the completion of enrollment in its SCOUT (Spineology Clinical Outcomes Trial) clinical trial, a prospective multicenter non-randomized performance goal investigation, designed to evaluate the safety and effectiveness outcomes in instrumented lumbar interbody fusion procedures for the treatment of degenerative disc disease (DDD).
TransS1 received two patents from the United States Patent and Trademark Office (USPTO) addressing presacral interbody fusion technologies, which includes new expandable cages designed to create lordosis at L5-S1 and a new sacroiliac fusion technique. The company’s portfolio is comprised of minimally invasive approachs with the Pylon system for posterolateral decortication and bone graft placement, KeyLIF MIS Oblique Lateral Interbody Fusion system and AxiaLIF presacral interbody fusion.