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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 / K252346

510(k) cleared

OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System

Astura Medical · Oct 21, 2025 · K252346

FDA cleared the OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System from Astura Medical on Oct 21, 2025 under K252346, a traditional 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 Jul 28, 2025. The decision came 85 days later, inside the 90 FDA-day goal for a 510(k).

Astura Medical has one other decision in the tracker over the last 12 months: K252885 (OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System).

Questions & Answers

What did FDA clear under K252346?

K252346 is the FDA 510(k) for OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System, submitted by Astura Medical. FDA's decision date was Oct 21, 2025, under product code NKB (Thoracolumbosacral Pedicle Screw System).

Who makes the OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System?

Astura Medical, based in Irving, TX, is the applicant of record for K252346.

How long did the K252346 review take?

FDA received the submission on Jul 28, 2025 and issued its decision on Oct 21, 2025, 85 days later.

← All decisions in October 2025

Sources