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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 / November 2025 / K243715

510(k) cleared

Synthes Patient Specific Implants

Synthes GmbH · Nov 12, 2025 · K243715

FDA cleared the Synthes Patient Specific Implants from Synthes GmbH on Nov 12, 2025 under K243715, 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 Dec 2, 2024. The decision came 345 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Synthes GmbH has 3 other decisions in the tracker over the last 12 months: K254093 (DePuy Synthes VOLT Medial Distal Femur 3.5 Plating System), K260069 (DePuy Synthes VOLT Proximal Tibia 3.5 Plating System), K254054 (VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating System).

Questions & Answers

What did FDA clear under K243715?

K243715 is the FDA 510(k) for Synthes Patient Specific Implants, submitted by Synthes GmbH. FDA's decision date was Nov 12, 2025, under product code GXN (Plate, Cranioplasty, Preformed, Non-Alterable).

Who makes the Synthes Patient Specific Implants?

Synthes GmbH, based in Zuchwil, is the applicant of record for K243715.

How long did the K243715 review take?

FDA received the submission on Dec 2, 2024 and issued its decision on Nov 12, 2025, 345 days later.

← All decisions in November 2025

Sources