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This month, we provide a look at three newer companies: Allevion Medical, Native Orthopaedics and Orthomod. Their recent product introductions provide solutions for spine surgery, soft tissue fixation and structural implants.
Allevion Medical | Vantage Lumbar Decompression Kit, K252546
Submitted August 2025, granted March 2026
Primary predicate: LESspine Innovations, ELID System, K243774
FYI: The clearance addresses a fully disposable, sterile system designed to simplify and enhance minimally invasive lumbar decompression. A key differentiator of Vantage is its direct visualization capability, supported by single-use integrated illumination that allows physicians to see the targeted anatomy throughout the procedure.
Features include:
- Reproducible, step-based workflow designed to support procedural safety and efficiency
- Minimally invasive approach designed to limit tissue disruption
- Precision tools engineered for depth-controlled bone resection
- Protective guards designed to help reduce the risk of damage to delicate structures
Founded in 2025, Allevion is based in Boca Raton, Florida, and leadership has marked significant time at the helm of SurGenTec.
Native Orthopaedics | Repair Construct
The knotless, intraoperatively adjustable suture fixation product is powered by the company’s two proprietary technologies: the Dragonfly finger trap and Zerofly integrated soft button fixation.
Cleared indications include soft tissue-to-bone fixation in the shoulder, foot and ankle, and knee with an initial commercial focus on various types of ACL and PCL repair.
Native Orthopaedics also received a third FDA 510(k) clearance for the Native Bridge, which is a novel construct intended for the fixation of bone to bone. The device is used as fixation posts, a distribution bridge or for distributing suture tension over areas of ligament or tendon repair in ACL/PCL repair.
Founded in 2024, Native Orthopaedics is based in Providence, Rhode Island. Leadership and staff bring experience from various roles at DePuy Synthes Spine, Johnson & Johnson MedTech, MiRus, Mitek Sports Medicine, Silony Medical, Smith+Nephew and Surgalign.
Orthomod | MOD-C Cervical Implant
The clearance marks the introduction of the calcium-acrylic modified polymer (CAMP) composite, marking a significant advancement in structural orthopedic implants. CAMP is a composite of an acrylic polymer and synthetic beta-tricalcium phosphate/hydroxyapatite designed with a broad range of potential applications in spine, reconstructive orthopedics, dentistry, sports medicine and oncology.
MOD-C is indicated for the treatment of degenerative disc disease of the cervical spine from C2-T1. This milestone represents the clearance of a novel, permanent biomaterial composite for use in orthopedic and spine surgery.
The MOD-C implant family is planned for clinical launch in the second half of 2026.
Orthomod, founded in 2023, is headquartered in Dayton, Ohio. Leadership brings experience from roles at companies that include Johnson & Johnson (Ethicon Endo-Surgery) and X-spine Systems/Xtant Medical.
