FDA 510(k) Recap: Companies Gaining First Clearances in 2018 and 2019
Products highlighted here – representing the spine, joint reconstruction, trauma and arthroscopy/soft tissue segments – include a total hip, cervical...
Jan 18 2019,
Products
Histogenics to Explore Strategic Alternatives for NeoCart based on FDA Findings
Histogenics expects to suspend development of NeoCart, a tissue engineered implant, after FDA indicated that an additional clinical trial would...
Jan 07 2019,
Integra LifeSciences Announces First Procedures with XT Revision Total Ankle
Integra XT represents one of the first FDA-cleared devices indicated specifically for revision arthroplasty. The system features include an augmented...
Dec 11 2018,
In2Bones: 4Q18 Product Launches Focus on Fracture Repair, Foot Deformities
These three products include a transparent PEEK implant for pediatric and adult flat foot deformity; titanium-alloy bone plates, also featuring...
Dec 11 2018,
DePuy Synthes: A Look at PUREVUE and 2018 Product Launches
The PUREVUE™ Visualization imaging platform, now available globally, has application in minimally invasive endoscopic surgery. We also recap the company’s...
Dec 11 2018,
Foot and Ankle Implant Opportunities Lie in Design, Technique Improvements
David Kay, M.D., a foot/ankle surgeon, shares what he see in his crystal ball regarding plates, biologics and total ankle...
Dec 05 2018,
FDA 510(k) Highlights from 2018: Shoulder and Ankle Joint Replacement Products on Tap
Several of these clearances reflect additions of stemless/short stem, glenoid components and reverse applications, as well as additively-manufactured and porous/porous-coated...
Nov 27 2018,
GEO CART Designed to Address Operating Room, Supply Chain Efficiency
Gramercy Extremity Orthopedics’ GEO CART® is a mobile storage and point-of-sale system that houses 2,000+ sterile-packed instruments and implants that...
Nov 27 2018,
DePuy Synthes to Co-Promote Ortho Development’s KASM Knee Spacer
The post-replacement device to treat infection complements DePuy Synthes’ rollout of its recently launched ATTUNE Revision knee. This strategic agreement...
Oct 23 2018,
Orthobiologics for Fracture Repair, Knee Cartilage Defects: 3Q18 Study Highlights
Bone Therapeutics (ALLOB® allogeneic bone cell therapy) and Histogenics (NeoCart® tissue-engineered knee implant) are two of the five companies we...
Oct 05 2018,
b-ONE Ortho Gains FDA 510(k) Clearance for Total Hip
The b-ONE™ cementless total hip system is the company’s first product following a US $20.0MM round of Series A financing....
Sep 26 2018,
NASS Preview: 14 Spine Products That Caught Our Attention
Between now and NASS 2018, we expect to hear more about new spine products that use additive manufacturing, more variations...
Sep 10 2018,
510(k) Recap: New Products from Companies You Know
We provide a recap of how companies including Additive Orthopedics, Arthrex, Corin, DJO, Exactech, Orthofix, Wright Medical, Zimmer Biomet and...
Aug 21 2018,
First Two United States Patients Receive CartiHeal’s Agili-C Implants
The Israeli startup develops implants to treat cartilage and osteochondral defects in traumatic and osteoarthritic joints; to date, 80 patients...
Aug 20 2018,
Ortho Development Announces First Surgery Using Balanced Knee System in China
The company’s BKS features implants and instrumentation that address primary and revision procedures. A patented locking mechanism is designed to...
Aug 20 2018,