WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / March 2026 / K254054

510(k) cleared

VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating System

Synthes GmbH · Mar 2, 2026 · K254054

FDA cleared the VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating System from Synthes GmbH on Mar 2, 2026 under K254054, a traditional 510(k). The device falls under product code HRS, Plate, Fixation, Bone, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Dec 17, 2025. The decision came 75 days later, inside the 90 FDA-day goal for a 510(k).

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), K243715 (Synthes Patient Specific Implants).

Questions & Answers

What did FDA clear under K254054?

K254054 is the FDA 510(k) for VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating System, submitted by Synthes GmbH. FDA's decision date was Mar 2, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating System?

Synthes GmbH, based in Zuchwil, is the applicant of record for K254054.

How long did the K254054 review take?

FDA received the submission on Dec 17, 2025 and issued its decision on Mar 2, 2026, 75 days later.

← All decisions in March 2026

Sources