FDA 510(k) Recap: First Clearances in 2020
We profile five companies that received their first FDA 510(k) clearances in 2020. Three of these companies are headquartered outside...
Sep 22 2020,
Products
10 Spine Companies Receive Their First FDA 510(k)
Thus far in 2020, ten companies received their FDA 510(k) clearances that were not only firsts for the company, but...
Sep 18 2020,
FDA 510(k) Recap: Total Ankle Clearances in 2020
The total ankle market is attractive for current and new players. We review four total ankle devices, three from new...
Aug 24 2020,
Exactech Transitions Stemless Shoulder to 3D Laser Printing
The bone-conserving anatomic total shoulder is now being manufactured using direct metal printing with high precision lasers to create its...
Jul 23 2020,
FDA 510(k) Recap: Spine Company Clearances
Spine continues to commercialize more products than other orthopedic sectors due to players of all sizes launching a robust list...
Jul 20 2020,
Engage Surgical Gains FDA Clearance for Cementless Partial Knee
This is reported to be the only cementless partial knee system available in the U.S. It is cleared for both...
Jul 08 2020,
IlluminOss Gains FDA Clearance for Treatment of Pelvic, Clavicle and Small-Bone Fractures
The new indication expansion significantly broadens opportunities to address the geriatric fragility fracture market....
Jul 08 2020,
FDA 510(k) Recap: Lesser-Known Companies and First Orthopedic Clearances
FDA cleared 40 orthopedic products in May. We highlight four companies that may be new names to you as well...
Jun 22 2020,
Smith+Nephew Launches INTELLIO Connected Tower for Sports Medicine
The new INTELLIO Connected Tower Solution wirelessly connects and remotely controls multiple Sports Medicine systems from outside the sterile field....
Jun 22 2020,
Spinal Elements Introduces the MIS Ultra Platform of Products and Procedures
Spinal Elements introduced its MIS Ultra platform of products and procedures designed to minimize the unintended consequences of spine surgery....
Jun 22 2020,
Winners Announced in For Such A Time As This – OrthoChallenge
Six ideas to help patients with musculoskeletal conditions have won the “For Such A Time As This – OrthoChallenge” innovation-promoting...
Jun 11 2020,
FDA 510(k) Recap: Line Extensions and Small Companies
FDA's orthopedic panel cleared 49 products in April, we’ve chosen updates from Arthrex, Medacta, OrthAlign, Akros Medical and Subchondral Solutions....
May 25 2020,
What Does the Next Generation of Total Ankles Need?
Preoperative planning, surgical instrumentation and bony ingrowth are advancements that surgeon Alan Davis, M.D., says are a must for future...
May 12 2020,
Embody Raises Funds for Soft Tissue Repair Technology
Funds will support commercial launch and postmarket clinical studies of the Tapestry system to treat serious tendon and ligament injuries....
May 11 2020,
Integrated Endoscopy Solves Arthroscope Design Challenges with NUVIS
The NUVIS system reduces wires and equipment with a single-use, HD arthroscope....
Apr 29 2020,