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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 / January 2026 / K252885

510(k) cleared

OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System

Astura Medical · Jan 22, 2026 · K252885

FDA cleared the OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System from Astura Medical on Jan 22, 2026 under K252885, a traditional 510(k). The device falls under product code PML, Bone Cement, Posterior Screw Augmentation, regulated at 21 CFR 888.3027 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 10, 2025. The decision came 134 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Astura Medical has one other decision in the tracker over the last 12 months: K252346 (OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System).

Questions & Answers

What did FDA clear under K252885?

K252885 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 Jan 22, 2026, under product code PML (Bone Cement, Posterior Screw Augmentation).

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 K252885.

How long did the K252885 review take?

FDA received the submission on Sep 10, 2025 and issued its decision on Jan 22, 2026, 134 days later.

← All decisions in January 2026

Sources