Draft Guidance Announced: 510(k) Submissions for Bone Anchors
FDA released draft guidance on Premarket Notification (510(k)) Submissions for Bone Anchors. Jan 04, 2017
Positive Long-Term Follow-Up Data for InSpace System
Long-term follow-up study results indicate that patients with massive rotator cuff tears that were treated with the OrthoSpace InSpace™ system showed improvements in function and pain at 6 weeks, with effects maintained for up to 5 years. Jan 04, 2017
DePuy Synthes Acquires Interventional Spine Expandable Cage Technology
DePuy Synthes entered into an asset purchase and development agreement with Interventional Spine, addressing expandable fusion cages and a facet screw system for open and percutaneous spine surgery. Jan 03, 2017
Precision Spine Receives FDA 510(k) Clearance for AccuFit Lateral Plate
Precision Spine received FDA 510(k) clearance for the AccuFit® Lateral Plating System. Jan 03, 2017
NuVasive to Resume XLIF Procedures in Japan in 1Q17
NuVasive received Japan regulatory approval for instruments used in the eXtreme Lateral Interbody Fusion (XLIF®) procedure. Jan 03, 2017
LIMA CORPORATE Awarded New ODEP Ratings
Lima Corporate was awarded three new Orthopaedic Data Evaluation Panel ratings for hip implants in the U.K. The ratings are intended to indicate that a device’s clinical performance falls in line with National Institute for Health and Care Excellence guidelines for implant survivorship. Jan 03, 2017
AxioMed/DSM Extend Terms on Exclusive License Agreement
AxioMed modified terms of a previously-signed 15-year exclusive license agreement with DSM Biomedical, holder of the patent on polymer technology used in AxioMed’s viscoelastic disc replacement. Dec 22, 2016
Limited U.S. Launch for Carevature’s Spinal Decompression System
Carevature commenced limited U.S. launch of Dreal™ products for spinal decompression. Full launch is slated for 2017. The system is also available for sale in the EU. Dec 21, 2016
Intrinsic Therapeutics Files PMA Application for Barricaid in Lumbar Discectomy
Intrinsic Therapeutics filed a Premarket Approval application with FDA for the Barricaid® Anular Closure device. Dec 21, 2016
ZipLine Medical Receives China Regulatory Approval for Zip Skin Closure System
ZipLine Medical received China Food and Drug Administration approval of its Zip® Surgical Skin Closure device. Dec 20, 2016
