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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 6-Jan-17 BY BLAKE MOSSY, JANUARY 6, 2017

M&A
DePuy Synthes (Johnson & Johnson) entered into an asset purchase and development agreement with Interventional Spine, Inc., a U.S.-based manufacturer of expandable cage and minimally invasive surgery (MIS) technologies for spinal fusion. Interventional Spine offers expandable cage technology that provides tactile feedback to surgeons, and features a continuously adjustable design, allowing the device's height to be customized to the patient's anatomy.Under the terms of the asset purchase, DePuy will acquire Interventional Spine's facet screw system for open and percutaneous spine surgery, a type of MIS procedure that aims to reduce the risk of complications and improve outcomes by utilizing small skin incisions without cutting the patient's underlying muscle. Through this deal, DePuy expands its expandable cage offerings to its core spine platform, a segment management believes will be help drive future growth.

REGULATORY
AxioMed announced an extension of term on its 15-year exclusive worldwide license with DSM Biomedical, holder of the patent on polymer technology used in AxioMed's viscoelastic disc replacement. Previously, AxioMed Spine and DSM revised and extended a licensing and supple agreement whereby DSM supplies its CarboSilThermoplastic Silicone-Polycarbonate-urethane material for AxioMed's Freedom lumbar and cervical discs.

The FDA released draft guidance on Premarket Notification (510(k)) Submissions for Bone Anchors, with recommendations for information and testing that should be included in premarket submissions for devices used in the appendicular skeleton for attachment of soft tissue to bone. This guidance is a reissuance of the Guidance Document for Testing Bone Anchor Devices from 1996, with updated content.

Globus Medical received CE Mark approval for its Excelsius GPS robotic trajectory guidance and navigation system, supporting minimally invasive and open orthopedic and neurosurgical procedures, with applications ranging from the cervical spine to the sacroilium, long bones and cranium. The system is designed to integrate with the company's implants and instruments, and is compatible with pre-operative CT, intra-operative CT and fluroscopic imaging modalities. Exclesius GPS aims to minimize radiation exposure, streamline workflow, and reproducibly assist in implant placement.

Implanet received a patent from the European Patent Office (EPO) covering its JAZZ implant universal tensioning system. The system is designed to treat spinal pathologies requiring vertebral fusion and it protected by four families of patents globally.

LIMA CORPORATE received three Othropaedic Data Evaluation Panel (ODEP) ratings for hip implants in the U.K. The rating are intended to indicate that a device's clinical performance falls in line with National Institute for Health and Care Excellence (NICE) guidelines for survivorship of total hip replacements.

Precision Spine received 510(k) clearance from the FDA for its AccuFit Lateral Plate, a low profile, titanium plating system that features four points of fixation for biomechanical rigidity and load sharing. The system is designed to match to the heights of Precision's ShurFit LLIF Interbody cages.

PRODUCT INTRODUCTION & UPDATE
OrthoPediatrics launched a new Distal Femoral Osteotomy System (DFOS), designed to include implants to treat several different femoral conditions and can be used to correct varus and valgus knee deformities. Instrumentation includes pin and cut guides to support accurate and reproducible placement.

Mazor Robotics received purchase orders for 21 surgical guidance systems during its fourth quarter, including four Mazor X trade-ins for Renaissance systems. Compared to last year's fourth quarter, system orders increased 75% and over the year, Mazor received orders for 62 systems, +138% versus 2015.

CLINICAL
OrthoSpace Ltd. announced the publication of long-term follow-up data for patients enrolled in an open-label, single-arm, prospective study evaluating the use of the InSpace System for the treatment of massive rotator cuff tears (RCTs). The study, published in the Archives of Orthopaedic and Trauma Surgery, reported that a cohort of 20 patients with irreparable, full-thickness RCTs showed improvements in shoulder function and subjective pain scores starting at six weeks of follow-up, with these gains maintained at up to five years.

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