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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 / K253345

510(k) cleared

JARVIS Diaphyseal Stem Standard

FH Industrie · Oct 29, 2025 · K253345

FDA cleared the JARVIS Diaphyseal Stem Standard from FH Industrie on Oct 29, 2025 under K253345, a special 510(k). The device falls under product code PHX, Shoulder Prosthesis, Reverse Configuration, regulated at 21 CFR 888.3660 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 30, 2025. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

FH Industrie has one other decision in the tracker over the last 12 months: K254003 (JARVIS Metaphyseal Stem).

Questions & Answers

What did FDA clear under K253345?

K253345 is the FDA 510(k) for JARVIS Diaphyseal Stem Standard, submitted by FH Industrie. FDA's decision date was Oct 29, 2025, under product code PHX (Shoulder Prosthesis, Reverse Configuration).

Who makes the JARVIS Diaphyseal Stem Standard?

FH Industrie, based in Quimper Finistere, is the applicant of record for K253345.

How long did the K253345 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Oct 29, 2025, 29 days later.

← All decisions in October 2025

Sources