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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 / K252958

510(k) cleared

METICULY Patient-specific titanium mesh implant

Meticuly Co., Ltd. · Jan 14, 2026 · K252958

FDA cleared the METICULY Patient-specific titanium mesh implant from Meticuly Co., Ltd. on Jan 14, 2026 under K252958, a traditional 510(k). The device falls under product code GXN, Plate, Cranioplasty, Preformed, Non-Alterable, regulated at 21 CFR 882.5330 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Sep 16, 2025. The decision came 120 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Meticuly Co., Ltd. has one other decision in the tracker over the last 12 months: K253206 (METICULY Patient-specific CMF solution).

Questions & Answers

What did FDA clear under K252958?

K252958 is the FDA 510(k) for METICULY Patient-specific titanium mesh implant, submitted by Meticuly Co., Ltd.. FDA's decision date was Jan 14, 2026, under product code GXN (Plate, Cranioplasty, Preformed, Non-Alterable).

Who makes the METICULY Patient-specific titanium mesh implant?

Meticuly Co., Ltd., based in Bangkok, is the applicant of record for K252958.

How long did the K252958 review take?

FDA received the submission on Sep 16, 2025 and issued its decision on Jan 14, 2026, 120 days later.

← All decisions in January 2026

Sources