Spine

Osseon® Therapeutics, Inc. announced today the commercial release in the U.S. of its newest product, the Osseoflex® SB steerable inflatable bone tamp. After successful launch and distribution in Europe, the Osseoflex SB has received FDA clearance for sale in the U.S.

DePuy Synthes Spine has announced the launch of the Spotlight® PL Access System, the first access system designed specifically for minimally invasive posterior-lateral fusion.

Prolific spinal device company K2M, Inc., has announced the global expansion of its breakthrough Rail 4D™ Technology at the 2012 North American Spine Society (NASS) Annual Meeting in Dallas, Texas. The technology is said to address the most complex spinal curves.

K2M is the largest privately owned company of its type in the world, focusing as it does on addressing complex spinal pathologies with innovative devices and solutions. It’s showing its wares at this year’s NASS meeting this week.

Integra LifeSciences Holdings Corporation has announced the launch of the Integra® CUSA® NXT Inferior Forward Bone Tip for its CUSA® NXT Ultrasonic Tissue Ablation System.

Precision Spine acquired Spinal USA earlier this year and is keen to make sure it builds on the event with its first big showing at the North American Spine Society meeting this week in Dallas, Texas.

The U.S. FDA has granted a Premarket Approval (“PMA”) Order for Paradigm Spine’s Coflex®, a minimally invasive, Motion Preserving Interlaminar Stabilization™ device for the treatment of Moderate To Severe Stenosis With Or Without Back Pain™.

Spinal device company Baxano sees its minimally invasive spinal fusion technology platform expand with the FDA’s clearance of its iO-Tome™ instrument for precise facet joint removal.

Amedica Corporation, a spinal and reconstructive medical device manufacturer, announced today it has received FDA 510(k) clearance to legally market a second generation family of cervical and lumbar interbody fusion devices manufactured with the company’s proprietary Silicon Nitride biomaterial. The product offers design enhancements the company says will allow surgeons to perform minimally invasive and lumbar lateral interbody fusion approaches.

New Jersey device company Precision Spine, Inc. has announced that it has received 510(k) clearance from the FDA its ReForm Pedicle Screw System. Physician/Developer says it will increase efficiency of application and ease ergonomic use.

NLT Spine’s eSPIN and PROW FUSION™ Together Offer a Complete Lumbar Interbody Fusion Procedure. FDA clearance means the system is good to go.

The first clinical use of Alphatec Spine’s NEXoss,™ synthetic bone graft has been announced. The material is indicated for use in posterolateral spine fusions in conjunction with bone marrow aspirate, autograft bone and appropriate hardware.

Precision Spine subsidiary Spinal USA, Inc., has received 510(k) clearance from the FDA for the Slimplicity® Solo Anterior Cervical Plate System, adding another important cervical product to its broad and expanding product portfolio.

Biomet is to be the exclusive distributor of Bonesupport’s proprietary Cerament™ bone void filler in an agreement which spans U.S. and Canada.

K2M, Inc., the device company focused on delivering minimally invasive solutions to complex spinal pathologies, has chosen the Scoliosis Research Society Annual meeting at which to announce the launch of its Serengeti® Complex Spine Minimally Invasive Retractor System.

Osseon® Therapeutics, Inc. has named Mr. Ron Clough as Chief Operating Officer. Mr. Clough has extensive experience with several companies that develop and market medical devices for the treatment of spinal disease and deformities…