March 23, 2018 | Blake Mossy
Life Spine received 510(k) approval from the FDA for its PLATEAU-LO Insert and Rotate Spacer System indicated for micro-invasive lumbar interbody fusions. The system is comprised of chamfered corners for ease of insertion and distraction, oblique lordosis, and a large, open graft window to maximize visibility and bone graft containment.
Exactech received 510(k) clearance from the FDA for its Novation XLE Vitamin E acetabular polyethylene liners for hip replacement. The liners are designed to work with the Novation Crown Cup Acetabular System which features InteGrip printed 3D porous material. The bearing material in the new XLE liners is designed for low wear and consists of vitamin E. Oxidation in-vivo can contribute to polyethylene degradation in orthopedic implant polyethylene.
Orthofix received 510(k) clearance from the FDA for its G-Beam Fusion Beaming system, indicated to provide alignment, stabilization and fixation for the treatment of neuropathic deformities such as Charcot food. The system is designed to fuse the medial and/or lateral columns, as well as bones in the hindfoot, in order to restore a stable foot that may ultimately reduce the probability of an amputation. The system is comprised of a single-use, sterile-packed implant.
PRODUCT INTRODUCTION & UPDATE
Aziyo Biologics launched its OsteGro allograft bone matrix, with application in spinal fusion, hip reconstruction and fractures. The system is comprised of cancellous bone and partially demineralized cortical bone, is easily molded and is easily molded to produce the desired shape and serves as a scaffold for new bone growth.
Tyber Medical launched its sterile Forefoot Procedure Kit of implants and instruments. The system is comprised of room setup disposables, instruments for soft tissue, bone and implant preparation, and the corresponding implants. The system aims to allow for flexibility in the treatment of bunion corrections, hammertoes, Aikens and Weil’s osteotomies.
Wright Medical launched its INVISION PROPHECY Preoperative Navigation for Total Ankle Revision. The system is the first pre-operative planning system with patient-specific instrumentation for ankle revision procedures. PROPHECY uses CT scan data to create alignment guides to support correct implant sizing and positioning, and can be used with or without failed implants in place.
KFx Medical entered into a licensing agreement with Wright Medical Technology relating to KFx patents used in knotless double row rotator cuff repair. Under the terms of the agreement, Wright and its affiliates will promote the use of products and techniques for knotless double row rotator cuff repair.