Tenon Medical(R) Announces FDA 510(k) Clearance for SImmetry(R)+ SI Joint Fusion System
Tenon Medical (NASDAQ:TNON) announced FDA 510(k) clearance for the SImmetry+ SI Joint Fusion System on October 21, 2025. The minimally invasive lateral-access system uses new 3D-printed titanium implants, joint decortication, bone graft delivery, and fixation to enable SI joint fusion. Tenon plans an alpha launch targeting year-end 2025 with select physician users to gather initial feedback ahead of broader commercial rollout. SImmetry+ joins Tenon's Catamaran platform, expanding multi-approach SI fusion options supported by published prospective studies.
Tenon Medical (NASDAQ:TNON) ha annunciato l'autorizzazione FDA 510(k) per il SImmetry+ SI Joint Fusion System il 21 ottobre 2025. Il sistema minimalmente invasivo a accesso laterale utilizza nuovi impianti in titanio stampati in 3D, decorticazione dell'articolazione, consegna di innesto osseo e fissazione per abilitare la fusione dell'articolazione sacroiliaca. Tenon prevede un lancio alfa mirato alla fine del 2025 con alcuni utenti medico selezionati per raccogliere feedback iniziali prima di una diffusione commerciale più ampia. SImmetry+ si aggiunge alla piattaforma Catamaran di Tenon, ampliando le opzioni di fusione SI con molteplici approcci supportati da studi prospettici pubblicati.
Tenon Medical (NASDAQ:TNON) anunció la aprobación 510(k) de la FDA para el SImmetry+ SI Joint Fusion System el 21 de octubre de 2025. El sistema de acceso lateral mínimamente invasivo utiliza implantes de titanio impresos en 3D, decorticación de la articulación, entrega de injerto óseo y fijación para permitir la fusión de la articulación sacroilíaca. Tenon planea un lanzamiento alfa con objetivo a finales de 2025 con usuarios médicos selectos para recabar comentarios iniciales antes de un despliegue comercial más amplio. SImmetry+ se une a la plataforma Catamaran de Tenon, ampliando las opciones de fusión SI de múltiples enfoques respaldadas por estudios prospectivos publicados.
Tenon Medical (NASDAQ:TNON)은 FDA 510(k) 승인을 받아 SImmetry+ SI Joint Fusion System에 대해 2025년 10월 21일에 발표했습니다. 이 최소침습 측면 접근 시스템은 3D 프린트 티타늄 임플란트, 관절 골화 제거, 골 이식재 전달 및 고정을 사용하여 SI 관절 융합을 가능하게 합니다. Tenon은 2025년 말 목표의 알파 출시를 선정된 의사 사용자를 대상으로 진행하여 초기 피드백을 수집하고 더 넓은 상용 출시를 준비합니다. SImmetry+는 Tenon의 Catamaran 플랫폼에 합류하여 여러 접근 방식의 SI 융합 옵션을 확장하며, 발표된 전향적 연구로 뒷받침됩니다.
Tenon Medical (NASDAQ:TNON) a annoncé l'autorisation FDA 510(k) pour le SImmetry+ SI Joint Fusion System le 21 octobre 2025. Le système d'accès latéral minimalement invasif utilise de nouveaux implants en titane imprimés en 3D, la décortication de l'articulation, la délivrance d'une greffe osseuse et la fixation pour permettre la fusion de l'articulation sacroiliaque. Tenon prévoit un lancement alfa visant la fin de 2025 avec des utilisateurs médecins sélectionnés pour recueillir des retours initiaux avant un déploiement commercial plus large. SImmetry+ rejoint la plateforme Catamaran de Tenon, élargissant les options de fusion SI à approches multiples, soutenues par des études prospectives publiées.
Tenon Medical (NASDAQ:TNON) hat eine FDA 510(k)-Freigabe für das SImmetry+ SI Joint Fusion System am 21. Oktober 2025 erhalten. Das minimalinvasive Lateralseitenzugangs-System verwendet neue 3D-gedruckte Titanimplantate, Gelenk-Decortikation, die Lieferung von Knochenersatzmaterial und Fixation, um die SI-Gelenk-Fusion zu ermöglichen. Tenon plant einen Alpha-Start mit Ziel Ende 2025 mit ausgewählten Arztanwendern, um erstes Feedback vor dem breiteren kommerziellen Rollout zu sammeln. SImmetry+ schließt sich der Catamaran-Plattform von Tenon an und erweitert die Optionen für multi-Ansatz-SI-Fusion, unterstützt von veröffentlichten prospektiven Studien.
Tenon Medical (NASDAQ:TNON) أعلنت تصريح FDA 510(k) لسيرفي سimuth SImmetry+ SI Joint Fusion System في 21 أكتوبر 2025. النظام الجانبي عبر الوصول من خلال جراحة طفيفة الغزارة يستخدم زراعات من التيتانيوم مطبوعة ثلاثية الأبعاد، وتنمية المفصل، وتوصيل طعوم العظم، وتثبيت لتسهيل دمج مفصل العانة الحِكمي. تخطط تينون لإطلاق إطلاق ألفي يستهدف نهاية 2025 مع مستخدمين من الأطباء المختارين لجمع التغذية الراجعة الأولية قبل طرح تجاري أوسع. ينضم SImmetry+ إلى منصة Catamaran من Tenon، موسعاً خيارات دمج SI متعددة الأساليب مدعومة من دراسات prospective منشورة.
Tenon Medical (NASDAQ:TNON) 宣布 FDA 510(k) 批准 SImmetry+ SI Joint Fusion System 于 2025年10月21日。该微创的侧向进入系统使用新的3D打印钛 Implant、关节去皮、骨移植材料递送与固定，实现髂骶关节（SI）关节融合。Tenon 计划在<2025年末进行一个< b>Alpha 启动，邀请部分医师用户以收集初步反馈，并在更广泛商业推广前进行准备。SImmetry+ 加入Tenon的Catamaran平台，扩大了多路径SI融合选项，并得到已发表的前瞻性研究支持。
- FDA 510(k) clearance for SImmetry+ (October 21, 2025)
- Alpha launch targeted by end of 2025 with select physician users
- Adds lateral approach complementing Catamaran inferior-posterior approach
- Backed by published prospective Mainsail and EVoluSIon SI fusion studies
- None.
Insights
FDA 510(k) clearance for SImmetry+ expands Tenon’s SI joint fusion portfolio and enables an alpha launch starting
Tenon adds the SImmetry+ System to its portfolio, combining 3D-printed titanium implants, decortication, bone graft delivery, and fixation to pursue true fusion via a minimally invasive lateral approach. The clearance permits limited market introduction and a targeted alpha launch by the end of the year to gather physician feedback before broader commercialization.
The primary dependencies include surgeon uptake during the alpha, real-world performance versus the existing Catamaran platform, and the company’s ability to scale training and supply. Reported clinical claims reference published studies for related products but no new clinical outcome data for SImmetry+ were provided here, so near-term commercial impact centers on adoption and feedback collection.
Watch for initial alpha user feedback, procedural metrics, and any follow-up clinical or registry data in the coming months; initial commercial signals should appear within the next
~Clearance expands Company's competitive advantage of clinically proven, minimally invasive technologies to treat debilitating SI joint conditions from multiple surgical approaches~
~SImmetry+'s New 3D printed titanium implants, robust joint decorticator, and simple bone graft delivery system provides physicians treatment options rooted in established fusion principles~
~Company initiating alpha launch of SImmetry® + with select group of physician users to provide initial feedback to support broader launch~
LOS GATOS, CA, AL / ACCESS Newswire / October 21, 2025 / Tenon Medical, Inc. (NASDAQ:TNON) ("Tenon" or the "Company"), a company transforming care for patients suffering with certain sacro-pelvic disorders, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the SImmetry+ SI Joint Fusion System. The SImmetry+ System is indicated for sacroiliac (SI) joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis, providing physicians with treatment options rooted in established fusion principles.
Utilizing the systems new 3D printed titanium implants and proprietary instrumentation, the SImmetry+ is a novel minimally invasive lateral access SI joint fusion system that uses proven orthopedic principles, including joint decortication, bone graft delivery, and fixation to achieve a true fusion. The Company is finalizing preparation for the initial alpha launch of the SImmetry+ targeting a launch by the end of the year. The alpha will provide important initial user feedback from a select group of physician users to support a broader market introduction in the coming months.
With this clearance, SImmetry+ now joins Tenon's Catamaran® SI Joint Fusion System in the Company's growing portfolio of advanced technologies. Together, these platforms uniquely position Tenon with multiple surgical approaches-lateral and inferior-posterior-both designed to be minimally invasive, enable authentic arthrodesis and supported by robust clinical evidence, including the published prospective Mainsail™ and EVoluSIon™ SI joint fusion studies. These differentiated technologies will enable physicians to customize treatment plans for their patients with an innovative portfolio that spans SI joint, spinal fusion, and deformity adjuncts - each solution engineered to deliver fusion outcomes more reliably. This multi-platform, multi-approach strategy strengthens Tenon's competitive advantage in the expanding SI joint fusion market and underscores the Company's commitment to delivering proven, durable outcomes for physicians and patients.
"Achieving true fusion of the SI joint is a major element of long-term stability for patients suffering from sacroiliac joint dysfunction. The new SImmetry+ System reflects an adherence to core AO principles-joint preparation, bone grafting, and rigid fixation-which are fundamental to successful bone healing" said Ali Araghi,DO, Orthopedic Spine Surgeon at the Core Institute in Phoenix, Arizona. "The introduction of the SImmetry+ SI joint system and its new 3D-printed titanium implant represents a meaningful advancement in SI joint fusion. The porous structure promotes bone ingrowth and biological fixation, while the precision-engineered threads and surface texture enhance initial stability across the joint. Combining these features with the SImmetry system's simple and proven minimally invasive approach to true arthrodesis has the potential to deliver more consistent fusion outcomes for my patients."
"The FDA clearance of SImmetry+ marks a significant inflection point in Tenon's growth trajectory," said Steven M. Foster, President and CEO of Tenon Medical. "By expanding our portfolio to include both the Catamaran and SImmetry+ systems, we have created a differentiated market position with multiple approaches to SI joint fusion backed by proven clinical outcomes including pain reduction, patient satisfaction, and independent confirmation of bridging bone fusion across the joint. This unique competitive advantage strengthens our ability to drive adoption, increase procedure volumes, and capture a larger share of this rapidly expanding market, all of which supports long-term value creation for our shareholders. We look forward to initiating our alpha launch of SImmetry and collaborating with our initial physician users to gain their feedback on performance and outcomes."
About Tenon Medical, Inc.
Tenon Medical, Inc., a medical device company formed in 2012, has developed The Catamaran SI Joint Fusion System that offers a novel, less invasive approach to the SI joint using a single, robust titanium implant. The system features the Catamaran™ Fixation Device which passes through both the axial and sagittal planes of the ilium and sacrum, stabilizing and transfixing the SI Joint along its longitudinal axis. The angle and trajectory of the Catamaran surgical approach is also designed to provide a pathway away from critical neural and vascular structures and into the strongest cortical bone. Since the national launch of the Catamaran SI Joint Fusion System in October 2022, Tenon is focused on three commercial opportunities with its System in the SI Joint market which include: 1) Primary SI Joint procedures, 2) Revision procedures of failed SI Joint implants and 3) Augmenting spinal fusion. For more information, please visit www.tenonmed.com.
The Tenon Medical logo shown above, and Catamaran®, PiSIF®, CAT PiSIF®, ETAD®, Posterior Inferior Sacroiliac Fusion®, CAT SIJ Fusion System®, Catamaran SIJ Fusion System®, Catamaran Inferior Posterior Fusion System®, Catamaran Transfixation Fusion System®, Catamaran Transfixation Fusion Device®, SImmetry® are registered trademarks of Tenon Medical, Inc. MAINSAILTM, and SImmetry+™ are also trademarks of Tenon Medical, Inc.
IR Contact:
Shannon Devine
203-741-8811
MZ North America
tenon@mzgroup.us
SOURCE: Tenon Medical, Inc.
View the original press release on ACCESS Newswire
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