With numerous FDA approvals, 2023 has proven to be a landmark year that paves the way for groundbreaking products. As we move into 2024, the spotlight is on American companies, particularly trailblazers like Eminent Spine and Astura Medical, which have been spearheading the approval process and already have captivating portfolios.
Eminent Spine, a leading figure in the medical technology sector, has exhibited commendable vigor in securing FDA approvals. The company’s proactive approach is evident in the diverse range of products slated for the 2024 release. Eminent Spine is focused on meeting regulatory standards but is also committed to delivering innovative solutions and creating a comprehensive and appealing product portfolio. Similarly, Astura Medical is poised to introduce many innovative products in 2024, contributing to the evolution of medical practices and patient care.
Additionally, a cohort of American companies, including VySpine, Flospine, Mirus, Xenix Medical, CTL Amedica, CoreLink, Curiteva, VGI, Surgentec, and Spinal Simplicity, among others, are actively working to augment and complete their portfolios. Remarkable, the FDA approved of Expanding Innovations’ X-PAC expandable system.
The notable dynamism and activity observed in these companies contrast with some key players in the industry. Except for Globus Medical, which continues to demonstrate innovation through products like Reflect, many major companies appear to be facing stagnation in bringing new and groundbreaking products to market.
Internationally, several companies outside the U.S. have secured FDA approvals for their products, showcasing the global collaboration driving advancements in medical technology. Companies like Solco, Implanet, and Spineway (VEOS system) have successfully navigated the FDA approval process.
To provide a comprehensive overview, we have curated a list of the top 20 FDA approvals in 2023 from our opinion. Below are the links to these groundbreaking approvals, offering a glimpse into the exciting developments that await in 2024:
- Eminent Spine’s 3D Titanium Lumbar Interbody Systems: PLIF/TLIF
- Eminent Spine’s 3D Titanium Lumbar Interbody Systems: ALIF
- Eminent Spine’s Cervical 3D Titanium Cages
- Astura Medical Receives FDA 510(k) Clearance For The Reunion Sacroiliac (SI) Joint Fusion System
- Astura Medical Receives FDA 510(k) Clearance For The Sirion X Expandable Lateral Lumbar Interbody Fusion System
- Astura Medical Receives FDA 510(k) Clearance For Olympic Deformity’s Sublaminar Bands Supplemental System
- Astura Medical Receives FDA 510(k) Clearance For EL CAPITAN X Expandable Anterior Lumbar Interbody System
- Vy Spine Announces FDA Clearance for its ClariVy OsteoVy PEKK Cervical IBF
- VySpine Announces FDA Clearances for VySpan, VyLam and VySpine Innovations
- VySpine Announces FDA Clearance for LumiVy Lumbar IBF with NanoVy Ti
- Spinal Simplicity Announces 510(K) FDA Clearance of Its Novel Sacroiliac Joint System, the Liberty-SI Lateral Implant
- FloSpine Revolutionizes Treatment for Spinal Stenosis with FDA Clearance of KeyLift™ System
- Xēnix Medical Receives FDA Clearance of SOLACE™ Sacroiliac Fixation System with NANOACTIV™ Nanotechnology
- MiRus Announces FDA 510(k) Clearance for Molybdenum-Rhenium (MoRe®) Low Profile Anterior Cervical and Lateral Lumbar Plating Systems
- SurGenTec’s TiLink-L Receives FDA Clearance, Leading the Way as the First Offering in its Advanced Sacroiliac Joint Fusion Portfolio
- FDA Awards CTL Amedica 510k Clearance for the NITRO Interbody Fusion Cage System Family
- Globus Medical Announces FDA Approval for its Non-Fusion Scoliosis Correction System, the Latest Advancement for Young Patients with Idiopathic Scoliosis
- VGI Medical, LLC Announces FDA Clearance of the Novel 3D Printed SiJoin® T3 Implant System, for Sacroiliac Joint Transfixation
- CoreLink Announces FDA Clearance of Siber® Ti–3D Printed SI Joint Fusion System
- Expanding Innovations, Inc. Announces FDA Approval of X-PAC Expandable Lateral Cage System
- Curiteva Inc. Announces FDA 510(k) Clearance for Inspire TM 3D Porous PEEK HA FUSETM Cervical Interbody System
The most important part of the recent product launches has centered around sacroiliac implants (6), 3D cages, and expandable technology (3). Notably, the approval of expandable cages from Astura Medical and Expanding Innovations signals a shift in the market dynamics for these types of implants, reducing the reliance on industry giant Globus Medical.
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