FDA 510(k) Review: 2019 Additively-Manufactured Product Clearances
Spine implants accounted for the majority of the additive manufactured products that received FDA 510(k) clearance in 2019. Our review...
Dec 02 2019,
Competitive Landscape
FDA 510(k) Recap: 10 Products in Joint Replacement and Spine
This month, we look at companies that received their first orthopedic-related clearance such as FX Shoulder USA, Amplify Surgical and...
Nov 18 2019,
Orthopedic Industry Investors Talk Funding Trends
Smart tools and technologies that increase supply chain or operating room efficiencies are on investors’ shortlists for deploying capital in...
Nov 18 2019,
Design for Manufacturing: An Engineer’s Guide to Machine Tools
This guide provides basic knowledge of how the drill press, mill, lathe, EDM and cutting tools operate, as well as...
Nov 18 2019,
New Trademark Laws Stress Quality and Integrity of Registration
The United States Patent and Trademark Office has enacted policy changes to post-use audits and foreign applications. The new laws...
Nov 18 2019,
CMS Increases Medicare Physician Payment for Minimally Invasive SI Joint Fusion
Companies affected by this change include RTI Surgical, marketer of the SImmetry® system, and SI-BONE, manufacturer of the iFuse Implant...
Nov 14 2019,
DiFusion Gains FDA Clearance for Xiphos ZFUZE Biomaterial
The first of its kind biomaterial is offered as an alternative to PEEK and titanium materials for interbody devices....
Nov 14 2019,
Smith+Nephew Launches OR30 Dual Mobility Hip
OXINIUM Technology is the first advanced bearing material available to support modular dual mobility throughout the entire offering....
Nov 14 2019,
Pristine Surgical Enters Sports Med Market with Single-Use Surgical Imaging System
Pristine Surgical is expected to launch to market an arthroscope that includes a single-use digital imaging platform in the first...
Nov 05 2019,
Stryker Boosts Extremities Portfolio with Wright Medical Acquisition
Stryker entered a definitive agreement to purchase Wright Medical, speeding the company's path to leadership in extremities....
Nov 04 2019,
FDA 510(k) Success Dependent upon Pre-submission Planning
How should you prepare for FDA 510(k) submissions in 2020? Start with a thorough understanding of the testing and verification...
Nov 04 2019,
FDA Applies Special Controls to Instrumentation for Certain Osteochondral Implants
FDA has ruled to classify orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation into class II (special controls)....
Nov 04 2019,
4 Key Elements of Design Controls
Design controls require an integrated and complex process that includes inputs and outputs, reviews, verification and validation, as well as...
Nov 01 2019,
WishBone Medical Enters Global Distribution Agreement with Optimal
WishBone Medical signed an agreement with logistics company Optimal, supporting global distribution of single-use, sterile packed orthopedic implants for pediatric...
Oct 31 2019,
DePuy Synthes to Promote TINAVI Robotic Solutions in China
Together, the companies will jointly promote the rapid development of digital surgery and technological medical innovation, providing insights for the...
Oct 31 2019,