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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / October 2025 / K253331

510(k) cleared

PressON Spinal Fixation System

Nexus Spine · Oct 14, 2025 · K253331

FDA cleared the PressON Spinal Fixation System from Nexus Spine on Oct 14, 2025 under K253331, a special 510(k). The device falls under product code NKB, Thoracolumbosacral Pedicle Screw System, regulated at 21 CFR 888.3070 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 30, 2025. The decision came 14 days later, inside the 90 FDA-day goal for a 510(k).

Nexus Spine has one other decision in the tracker over the last 12 months: K261279 (DeltaNEC Interbody System).

Questions & Answers

What did FDA clear under K253331?

K253331 is the FDA 510(k) for PressON Spinal Fixation System, submitted by Nexus Spine. FDA's decision date was Oct 14, 2025, under product code NKB (Thoracolumbosacral Pedicle Screw System).

Who makes the PressON Spinal Fixation System?

Nexus Spine, based in Salt Lake City, UT, is the applicant of record for K253331.

How long did the K253331 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Oct 14, 2025, 14 days later.

← All decisions in October 2025

Sources