Orthofix Announces FDA Clearance, Limited Launch of FORZA PTC Interbody Spacer
Orthofix announced FDA 510(k) clearance and U.S. limited launch of the FORZA® PTC™ (Peek Titanium Composite) Spacer. May 16, 2016
First Ray Receives FDA 510(k) Clearance for CortiClamp Small Bone Fixation System
First Ray received FDA 510(k) clearance for the CortiClamp™ System for small bone fixation. May 16, 2016
Xtant Medical Receives FDA Clearance for Posterior Cervical Screw Indication on Certex Spinal Fixation
Xtant Medical received FDA 510(k) clearance of a posterior cervical screw indication for the Certex® Spinal Fixation system. May 13, 2016
Tecres and Keensight to Form Demetra
Demetra Holding has formed with investment from Tecres and Keensight, which acquired aap Implantate’s biomaterials assets. May 12, 2016
Initial Cases Performed with Life Spine PROLIFT Expandable Interbody System
Life Spine announced successful completion of initial cases with the PROLIFT® Expandable Interbody System for minimally invasive PLIF, TLIF and oblique approaches. May 12, 2016
Strategic Orthopaedic-related 510(k)s issued in April 2016
Strategic orthopaedic-related 510(k)s issued in April 2016 include: Olympic Posterior Spinal Fixation System (Astura Medical); Revival Modular Revision Hip Stem (Corin); Internal Bone Staple, Bicortical Fixation Screw & Washer Nut System (First Ray*); G3 Active Plate Small Fragment System (Genesis Fracture Care); Maxigen Bone Void Filler (Hans Biomed); Osteopal Plus Bone Cement (Heraeus); Pedicle Screw System (icotec); Revolution Spinal Fixation System (Intelligent Implant); Glenoid Positioning System (Materialise); Ultra Telescope (Olympus Winter); White Pearl Preferred Angle Anterior Cervical Plate (Osseus Fusion); Starfuse Interphalangeal Pin, Osteobullet Compression Screw (Phalanx Innovations*) (View the full list of orthopaedic 510(k)s for April 2016) May 11, 2016
aap Implantate Completes Sale of Biomaterials Unit
aap Implantate completed the sale of its aapBiomaterials subsidiary. The buyer is Keensight Capital. May 11, 2016
100 Surgeries with ROSA Spine
Medtech announced that 100 spinal surgeries have been successfully performed with the ROSA™ Spine robotic-assistive device for minimally invasive surgery. May 11, 2016
OrthoPediatrics Enters Japan Market
OrthoPediatrics received Japan regulatory clearance for RESPONSE™ Spine for use in pediatric and adult patients. The product will be distributed regionally through an exclusive agreement with Robert Reid. May 11, 2016
First Surgeries with Safe Orthopaedics’ SteriSpineCC Range
Safe Orthopaedics confirmed initial successful surgeries using SteriSpine™CC devices, for use in the cervical spine. Full launch is planned for 3Q16. May 11, 2016
